A handful of other six-star systems have been discovered, but this one is unique.
— NYT: Top Stories
Author: Michelle Dryden
Expands Focus on Sulfur Nutrition for Wide Variety of Crops Including Soybeans
Robust Operational Performance Supports Improved Granular Conversion
Acquires Certain Assets of Commonwealth Industrial Services (CIS), Adding Packaging, Warehousing and Logistics Capabilities
PARSIPPANY, N.J. & HOPEWELL, Va. — (BUSINESS WIRE) — AdvanSix (NYSE: ASIX) said today it continues to build on the company’s longstanding leadership and expertise in ammonium sulfate and sulfur nutrition while creating further opportunities for growth and efficiencies across the value chain. The company shared details of recent activities, including investment in soybean application research, marketing and grower education, operational improvements and the acquisition of certain assets of Commonwealth Industrial Services, Inc. (CIS), an ammonium sulfate packaging, warehousing and logistics services business based in Hopewell, Va.
“AdvanSix is a leader in plant nutrients, producing top-quality ammonium sulfate at our Hopewell facility – which is the largest single-site producer in the world – for nearly 70 years,” said Erin Kane, president and CEO of AdvanSix. “We continue to see increased demand for sulfur nutrition, and ammonium sulfate is proven to deliver pound-for-pound the most readily available sulfur and nitrogen to a wide variety of crops, including wheat, cotton, corn and soybeans. We remain committed to our growth in this area and to advancing grower education and research that validates the return on investment and effectiveness of ammonium sulfate to support the success of our customers.”
Value of Ammonium Sulfate on Soybeans
Today’s modern soybean varieties require better management of essential nutrients, like nitrogen and sulfur, throughout the planting season to maximize and enhance their yield potential.
Ammonium sulfate is an efficient, versatile and proven source of critical nutrients that substantially improve crop production, according to lab and field trials conducted by prominent university researchers. The company is now working to educate growers and retailers about these results, especially the benefits of ammonium sulfate, which adds sulfur and supplemental nitrogen to their soybean crop management plans. With soybean prices currently at a seven-year high and season ending stocks projected to be down over 70% from the previous year, farmers have a great opportunity by boosting production through new nutrient management strategies.
Research has shown yield increases as much as 10 or more bushels per acre. These findings also demonstrate the importance of sulfur in improving plant health throughout the growing season, especially as clean air regulations have led to less sulfur in the air that is available to crops.
For more information on the value of Ammonium Sulfate for soybeans, visit soybeans.advansix.com.
Increase in Granular Grade Ammonium Sulfate
Operational excellence continues to be a key focus and priority for AdvanSix with initiatives underway targeting improvements in rate, cost, quality and yield. As a result of these efforts and recent enhancements in crystallizer technology and operations, the company is now producing more high-quality granular grade ammonium sulfate to meet the growing demand of our customers.
The company is now targeting conversion of approximately 65% of the ammonium sulfate produced in higher-value granular form, an increase of approximately 5%.
Packaged Ammonium Sulfate
The recent acquisition of certain assets of CIS enables AdvanSix to expand its offering to directly supply packaged ammonium sulfate to customers, primarily in North and South America. It diversifies and optimizes our offerings to include spray-grade adjuvant to support crop protection, as well as other specialty fertilizers and products for industrial use. The company also expects the addition of packaging and warehousing capabilities to bolster logistics and operational efficiency in the Richmond, Va.-area plants.
“AdvanSix has been both a supplier to and customer of CIS for many years, and we understand the business well. This acquisition extends our industry-leading value chain for ammonium sulfate and creates further opportunities for us to quickly diversify and optimize our offerings to serve existing and new customers,” said Mike Hamilton, vice president, Plant Nutrients at AdvanSix.
About AdvanSix
AdvanSix is a leading manufacturer of Nylon 6, a polymer resin which is a synthetic material used by our customers to produce fibers, filaments, engineered plastics and films that, in turn, are used in such end-products as carpets, automotive and electronic components, sports apparel, food packaging and other industrial applications. As a result of our backward integration and the configuration of our manufacturing facilities, we also sell caprolactam, ammonium sulfate fertilizer, acetone and other intermediate chemicals, all of which are produced within unit operations across our integrated manufacturing value chain. More information on AdvanSix can be found at http://www.advansix.com.
Forward Looking Statements
This release contains certain statements that may be deemed “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, that address activities, events or developments that our management intends, expects, projects, believes or anticipates will or may occur in the future are forward-looking statements. Forward-looking statements may be identified by words such as “expect,” “anticipate,” “estimate,” “outlook,” “project,” “strategy,” “intend,” “plan,” “target,” “goal,” “may,” “will,” “should” and “believe” and other variations or similar terminology and expressions. Although we believe forward-looking statements are based upon reasonable assumptions, such statements involve known and unknown risks, uncertainties and other factors, many of which are beyond our control and difficult to predict, which may cause the actual results or performance of the Company to be materially different from any future results or performance expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to: general economic and financial conditions in the U.S. and globally, including the impact of the coronavirus (COVID-19) pandemic and any resurgences; the scope and duration of the pandemic and pace of recovery; the timing of the development and distribution of an effective vaccine or treatment for COVID-19; governmental, business and individuals’ actions in response to the pandemic, including our business continuity and cash optimization plans that have been, and may in the future be, implemented; the impact of social and economic restrictions and other containment measures taken to combat virus transmission; the effect on our customers’ demand for our products and our suppliers’ ability to manufacture and deliver our raw materials, including implications of reduced refinery utilization in the U.S.; our ability to sell and provide our goods and services, including as a result of travel and other COVID-19-related restrictions; the ability of our customers to pay for our products; and any closures of our and our customers’ offices and facilities; risks associated with increased phishing, compromised business emails and other cybersecurity attacks and disruptions to our technology infrastructure; risks associated with employees working remotely or operating with a reduced workforce; risks associated with our indebtedness including compliance with financial and restrictive covenants, and our ability to access capital on reasonable terms, at a reasonable cost or at all due to economic conditions resulting from COVID-19 or otherwise; the impact of scheduled turnarounds and significant unplanned downtime and interruptions of production or logistics operations as a result of mechanical issues or other unanticipated events such as fires, severe weather conditions, natural disasters and pandemics including the COVID-19 pandemic; price fluctuations, cost increases and supply of raw materials; our operations and growth projects requiring substantial capital; growth rates and cyclicality of the industries we serve including global changes in supply and demand; failure to develop and commercialize new products or technologies; loss of significant customer relationships; adverse trade and tax policies; extensive environmental, health and safety laws that apply to our operations; hazards associated with chemical manufacturing, storage and transportation; litigation associated with chemical manufacturing and our business operations generally; inability to acquire and integrate businesses, assets, products or technologies; protection of our intellectual property and proprietary information; prolonged work stoppages as a result of labor difficulties or otherwise; cybersecurity, data privacy incidents and disruptions to our technology infrastructure; failure to maintain effective internal controls; disruptions in transportation and logistics; our inability to achieve some or all of the anticipated benefits of our spin-off including uncertainty regarding qualification for expected tax treatment; fluctuations in our stock price; and changes in laws or regulations applicable to our business. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Such forward-looking statements are not guarantees of future performance, and actual results, developments and business decisions may differ from those envisaged by such forward-looking statements. We identify the principal risks and uncertainties that affect our performance in our filings with the Securities and Exchange Commission (SEC), including the risk factors in Part 1, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2019, as updated in subsequent reports filed with the SEC.
Contacts
Media
Debra Lewis
(973) 526-1767
Investors
Adam Kressel
(973) 526-1700
Categories
Joe Biden’s Catholic moment
The new president elevates a liberal Catholicism that once seemed destined to fade away.
— NYT: Top Stories
People stand in front of police officers during a protest against the jailing of opposition leader Alexei Navalny in Moscow, Russia, Saturday, Jan. 23, 2021. Russian police on Saturday arrested hundreds of protesters who took to the streets in temperatures as low as minus-50 C (minus-58 F) to demand the release of Alexei Navalny, the country’s top opposition figure. (AP Photo/Pavel Golovkin)
MOSCOW (AP) — The spokesman for Russian President Vladimir Putin says the U.S. Embassy’s statements about the nationwide protests, in which more than 3,500 people reportedly were arrested, interfere in the country’s domestic affairs and encourage Russians to break the law.
Dmitry Peskov made the criticism on Sunday, a day after protests took place across the country demanding the release of jailed opposition leader Alexei Navalny, an anti-corruption activist who is Putin’s most well-known critic.
During the protests, embassy spokeswoman Rebecca Ross said on Twitter that “the U.S. supports the right of all people to peaceful protest, freedom of expression. Steps being taken by Russian authorities are suppressing those rights.” The embassy also tweeted a State Department statement calling for Navalny’s release.
Peskov said the statements “indirectly constitute absolute interference in our internal affairs” and are “direct support for the violation of the law of the Russian Federation, support for unauthorized actions.”
The protests attracted thousands of people in Russia’s major cities, including an estimated 15,000 in Moscow, and demonstrations occurred in scores of other cities. Peskov, however, dismissed the turnout as insignificant.
“Now many will say that many people came out for the illegal actions. No, few people came out; many people vote for Putin,” he said.
The 44-year-old Navalny, Putin’s most prominent and persistent foe, was arrested Jan. 17 when he returned to Russia from Germany, where had been recovering from severe nerve-agent poisoning that he blames on the Kremlin and that Russian authorities deny.
Authorities said his five-month stay in Germany violated terms of a suspended sentence that was imposed in a 2014 fraud and money-laundering conviction, which he says is fraudulent and politically motivated.
He is to appear in court on Feb. 2 for a hearing on whether the suspended sentence will be converted to 3 1/2 years in prison.
— Associated Press
Categories
America’s other front line
As the Biden administration proposes additional pandemic relief, nonprofit workers see a country facing a growing crisis.
— NYT: Top Stories
JoJo Siwa came out as a member of the LGBTQ community over the weekend.
— FOX News
TRENTON, N.J. — Looking forward to the next phase of the COVID-19 pandemic response, Mercer County has opened a COVID-19 vaccination facility at CURE Arena in Trenton this week.
The vaccination clinic will be a partnership of the CURE Arena with Capital Health, which will manage the site, announced County Executive Brian M. Hughes recently.
“We are committed to doing everything we can to help get eligible people vaccinated as quickly as possible,” Mr. Hughes said.
“We had a successful partnership with Capital Health during the COVID-19 testing program we established last spring, and I can’t think of a more fitting partner for this next phase of the pandemic response – the vaccination phase,” he said.
Like other vaccination sites, the arena facility will be for those eligible under the state’s phasing plan that is designed to prioritized those who are most at risk.
The public is advised to pre-register to receive vaccinations through the New Jersey Vaccination Scheduling System at https://covidvaccine.nj.gov.
Pre-registered individuals who are eligible will be notified when to make a vaccination appointment.
All vaccination sites currently require appointments.
State officials said they will have a consumer call center up and running soon, to assist people without Internet access for scheduling appointments, and to help answer general inquiries and questions.
Mercer County is also working on opening other sites, such as the new site at Mercer County Community College (MCCC).
The CURE Insurance Arena and MCCC locations will supplement, not replace, smaller vaccination sites including those currently being operated by municipal health departments and other health care facilities in Mercer County.
Vice President of Clinical Performance at Capital Health Louis F. D’Amelio, M.D., FACS, who manages the CURE Arena site said, “Capital Health has been taking an organized approach to meet the needs of the community during the COVID-19 pandemic.”
On partnering with the CURE Arena, he said, “we are excited to get started because we know that every vaccine we administer will help save a life and is a step closer to ensuring community protection against COVID-19…”
Earlier this week, the state also expanded the current vaccination eligibility to people 65 and older, and to those 16 to 64 who have certain chronic medical conditions that increase their risk of severe illness from the virus.
For more information on the CURE Insurance Arena and MCCC vaccination sites, email publichealth@mercercounty.org.
In CheckMate -9ER, OPDIVO in combination with CABOMETYX doubled median progression-free survival and objective response rate and showed superior overall survival vs. sunitinib1
Approved across all International Metastatic Renal Cell Carcinoma Database Consortium risk categories1,2
Approval expands Company’s presence in first-line advanced renal cell carcinoma, which includes OPDIVO + YERVOY as a standard of care for intermediate- or poor-risk patients3
PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #BMS—Bristol Myers Squibb (NYSE: BMY) today announced that OPDIVO® (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with CABOMETYX® (cabozantinib) 40 mg once daily tablets was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).1 The approval is based on the Phase 3 CheckMate -9ER trial, which compared OPDIVO in combination with CABOMETYX (n=323) versus sunitinib (n=328) in patients with advanced RCC.1 This application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible. 4 Please see below for additional CheckMate -9ER data context.
“At Bristol Myers Squibb, we are focused on developing transformative medicines that may improve survival for people living with cancer. The role of OPDIVO + YERVOY is well established for intermediate/poor-risk patients with advanced RCC, and today’s achievement extends the potential of an OPDIVO-based combination to even more patients,” says Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb.1 “OPDIVO in combination with CABOMETYX brings together the strong heritage of both medicines to now provide physicians a new combination in advanced RCC that may offer improved outcomes to patients for whom an immunotherapy plus tyrosine kinase inhibitor regimen is appropriate.”1
OPDIVO and YERVOY are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when OPDIVO is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1 Please see the Important Safety Information section below.
“This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib – progression-free survival, overall survival and objective response rate – while showing a low rate of treatment discontinuations due to side effects. The therapeutic benefit demonstrated in CheckMate -9ER and quality of life measures explored emphasize the role of this combination for patients with advanced kidney cancer,” said Toni Choueiri, M.D., director, Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School.1,2 “With this important FDA approval, the combination is poised to become a standard in newly diagnosed metastatic kidney cancer.”
In the CheckMate -9ER trial, the primary endpoint was progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR), and the secondary endpoints included overall survival (OS) and BICR-assessed objective response rate (ORR).1 In the trial, patients treated with OPDIVO in combination with CABOMETYX lived twice as long without their tumors progressing as patients who were treated with sunitinib (median PFS was 16.6 months [95% Confidence Interval [CI]: 12.5-24.9] versus median PFS of 8.3 months [95% CI: 7.0-9.7]; [Hazard Ratio [HR]: 0.51 [95% CI: 0.41–0.64], P<0.0001; median follow-up of 18.1 months]; range: 10.6-30.6 months).1,2 OPDIVO in combination with CABOMETYX also reduced the risk of death by 40% compared to sunitinib (HR: 0.60 [98.89% CI 0.40–0.89]; P=0.0010; median OS was not reached for OPDIVO in combination with CABOMETYX and not available for sunitinib [range: 22.6-NR months]).1
Additionally, more patients responded to OPDIVO in combination with CABOMETYX than sunitinib, with an ORR of 55.7% (n=180/323) (95% CI: 50.1 to 61.2) versus 27.1% (n=89/328) (95% CI: 22.4 to 32.3); P<0.0001, respectively.1 In the combination arm, 8.0% (n=26/323) of patients experienced a complete response and 47.7% (n=154/323) experienced a partial response versus 4.6% (n=15/328) and 22.6% (n=74/328) of those treated with sunitinib.1,2 Among patients who responded, the median duration of response was 20.2 months for OPDIVO in combination with CABOMETYX (95% CI: 17.3 to NA) and 11.5 months for sunitinib (95% CI: 8.3 to 18.4).1 Consistent results for PFS were observed across pre-specified subgroups of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk categories and PD-L1 tumor expression status.1
Adverse reactions greater than Grade 3 in the trial were similar with OPDIVO in combination with CABOMETYX versus sunitinib (75% versus 71%).2 All-cause adverse reactions leading to discontinuation of either OPDIVO or CABOMETYX occurred in 19.7% of patients; 6.6% of OPDIVO only, 7.5% of CABOMETYX only and 5.6% of the combination due to same adverse reaction at the same time.1,5
“While significant progress has been made in the treatment landscape for advanced kidney cancer over the last several years, patients still need more therapeutic options to treat this disease as we search for a possible cure,” said Bryan Lewis, president and co-founder of KidneyCAN.6,7 “As patients are living longer with advanced kidney cancer, focusing on the safety and effectiveness of new treatments has become even more important. The findings for the combination of OPDIVO and CABOMETYX in the CheckMate -9ER trial make the FDA approval of this combination a notable development for the patient community.”1
About CheckMate -9ER
CheckMate -9ER is an open-label, randomized, Phase 3 trial evaluating patients with previously untreated advanced renal cell carcinoma (RCC).1 A total of 651 patients (22% favorable risk, 58% intermediate risk, 20% poor risk) were randomized to OPDIVO in combination with CABOMETYX (n=323) versus sunitinib (n=328).1 Patients were randomized to receive 240 mg of OPDIVO every two weeks intravenously and 40 mg of CABOMETYX orally daily or sunitinib 50 mg orally daily for the first four weeks of a six-week cycle.1 Treatment with OPDIVO continued until disease progression per Response Evaluation version 1.1 (RECIST v1.1) or unacceptable toxicity.1 The recommended dosing for OPDIVO and CABOMETYX is 240 mg of OPDIVO every two weeks or 480 mg every four weeks in combination with 40 mg of CABOMETYX once daily administered orally without food.1 The recommended treatment for OPDIVO is until disease progression, unacceptable toxicity or up to two years.1 Treatment with CABOMETYX is until disease progression or unacceptable toxicity.1 The primary endpoint was progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR), using RECIST v1.1.1 Secondary endpoints included overall survival (OS) and objective response rate (ORR), the latter of which was assessed by BICR using RECIST v1.1.1 The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.
Select Safety Profile from CheckMate -9ER Study
Adverse reactions leading to discontinuation of either OPDIVO or CABOMETYX occurred in 19.7% of patients: 6.6% OPDIVO only, 7.5% CABOMETYX only and 5.6% both drugs due to the same adverse reaction at the same time.1,5 Adverse reactions leading to dose interruption or reduction of either OPDIVO or CABOMETYX occurred in 83% of patients: 3% OPDIVO only, 46% CABOMETYX only, 21% both drugs due to same adverse reaction at the same time and 6% both drugs, sequentially.1 Serious adverse reactions occurred in 48% of patients receiving OPDIVO in combination with CABOMETYX (n=320).1 The most frequent (≥2%) serious adverse reactions in those patients were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection and hyponatremia.1 Fatal intestinal perforations occurred in 3 (0.9%) patients.1 The most common (≥20%) adverse reactions of any grade in patients receiving OPDIVO and CABOMETYX were diarrhea (64%), fatigue (51%), hepatotoxicity (44%), palmar-plantar erythrodysaesthesia syndrome (40%), stomatitis (37%), rash (36%), hypertension (36%), hypothyroidism (34%), musculoskeletal pain (33%), decreased appetite (28%), nausea (27%), dysgeusia (24%), abdominal pain (22%), cough (20%) and upper respiratory tract infection (20%).1
About Renal Cell Carcinoma
Renal cell carcinoma (RCC) is the most common type of kidney cancer in adults, accounting for approximately 15,000 deaths in the United States each year.8,9 RCC is approximately twice as common in men as in women.10 In the United States, the five-year survival rate, based on data from 2010 to 2016, for those diagnosed with metastatic (or advanced) kidney and renal pelvis cancer is 13%.9
INDICATIONS
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
IMPORTANT SAFETY INFORMATION
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.
Immune-Mediated Pneumonitis
OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%).
Immune-Mediated Colitis
OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).
Immune-Mediated Hepatitis and Hepatotoxicity
OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).
OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.
Immune-Mediated Endocrinopathies
OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.
In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%).
In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%).
In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.5%) and Grade 2 (2.2%).
In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%), and Grade 2 (4.5%).
In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%).
In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2.7% (15/666) of patients, including Grade 4 (0.6%), Grade 3 (0.3%), and Grade 2 (0.9%).
Immune-Mediated Nephritis with Renal Dysfunction
OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%).
Immune-Mediated Dermatologic Adverse Reactions
OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.
YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/ exfoliative rashes.
Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated rash occurred in 16% (108/666) of patients, including Grade 3 (3.5%) and Grade 2 (4.2%).
Other Immune-Mediated Adverse Reactions
The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.
In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.
Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.
Infusion-Related Reactions
OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients.
Complications of Allogeneic Hematopoietic Stem Cell Transplantation
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.
Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.
Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone
In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
Lactation
There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.
Serious Adverse Reactions
In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY (n=547). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 9ER, serious adverse reactions occurred in 48% of patients receiving OPDIVO and cabozantinib (n=320). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection, and hyponatremia. Fatal intestinal perforations occurred in 3 (0.9%) patients.
Common Adverse Reactions
In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%). In Checkmate 9ER, the most common adverse reactions (≥20%) in patients receiving OPDIVO and cabozantinib (n=320) were diarrhea (64%), fatigue (51%), hepatotoxicity (44%), palmar-plantar erythrodysaesthesia syndrome (40%), stomatitis (37%), rash (36%), hypertension (36%), hypothyroidism (34%), musculoskeletal pain (33%), decreased appetite (28%), nausea (27%), dysgeusia (24%), abdominal pain (22%), cough (20%) and upper respiratory tract infection (20%).
Contacts
Bristol Myers Squibb
Media Inquiries:
Media@BMS.com
Investors:
Tim Power
609-252-7509
- America’s #1 Sportsbook to Debut Alongside Casino in Partnership with MotorCity Casino
NEW YORK — (BUSINESS WIRE) — Today, FanDuel Group, in collaboration with MotorCity Casino, launched a fully integrated, real money online gaming experience for residents and visitors to the state of Michigan. The FanDuel Sportsbook & Casino app and the standalone FanDuel Casino app are both available for iOS and Android. As a complement to FanDuel’s popular fantasy sports app, customers in Michigan can now use fantasy sports, sportsbook and casino winnings interchangeably between products.
Michigan marks the tenth state where FanDuel offers mobile sports betting, joining New Jersey, West Virginia, Pennsylvania, Indiana, Colorado, Illinois, Iowa, Tennessee and Virginia. The online sports betting launch today complements the state-of-the-art FanDuel Sportsbook at MotorCity Casino in Detroit that opened in March 2020. It also marks the third state where FanDuel offers mobile casino games, joining New Jersey and Pennsylvania.
The FanDuel Sportsbook app will feature a special risk-free first bet up to $1,000 for new customers in Michigan.* FanDuel will refund the amount of a customer’s first wager, up to $1,000, within 72 hours. FanDuel Sportsbook, America’s #1 Sportsbook, is bringing its best-in-class online sports betting experience to sports fans who will be able to place wagers anywhere in the state across professional and college football, basketball, baseball, golf, MMA, soccer, and tennis with a variety of betting and payment options available. The FanDuel Sportsbook app in Michigan is simple, secure, and convenient, with a number of key features, including:
- New Way to Parlay: FanDuel is the only U.S. sportsbook with Same Game ParlayTM bets, which is the ability to build a parlay utilizing betting markets from the same game.
- FanDuel Group’s Account and Wallet Technology: FanDuel Group has developed its own account and wallet technology in-house that is the backbone of the new operating system on the FanDuel app in Michigan. FanDuel Sportsbook utilizes its own proprietary risk and trading technology and leverages the IGT PlaySports platform.
- Absurdly Customer Focused: FanDuel Sportsbook offers safe and secure banking, lightning-fast payouts usually within twenty-four hours, a Cash Out early feature and 24/7 customer service.
- The Host with Most: Mike Valenti, host of the Mike Valenti Show with Rico on WXYT-FM, will be FanDuel’s sports betting ambassador in Detroit.
- Detroit Pistons: FanDuel Sportsbook and MotorCity Casino are official sports betting partners of the Detroit Pistons.
Responsible Gaming: The FanDuel Sportsbook also has account protections in place and a global reputation for responsible wagering.
In Michigan, FanDuel will offer casino games via two mobile apps – the standalone FanDuel Casino app, and within the “casino lobby” of the FanDuel Sportsbook app. New FanDuel Casino players can play their first day risk-free up to $200. FanDuel Casino will refund any losses up to $200 during the first 24 hours of placing their first casino wager (losses refunded as casino site credit). The standalone FanDuel Casino, also in collaboration with MotorCity Casino, is available today for download on iOS and Android or via web at casino.fanduel.com. New customers can sign up for an account or use their FanDuel Sportsbook account or daily fantasy account to login and play. The FanDuel Casino app has an expanded library featuring slots, blackjack games, roulette games, video poker games and baccarat games. FanDuel Casino makes it secure and simple to cash out winnings, and players will receive the same customer support, convenience, safety, and security that customers have come to expect from FanDuel.
*Offer is available for a limited time.
About FanDuel Group
FanDuel Group is an innovative sports-tech entertainment company that is changing the way consumers engage with their favorite sports, teams, and leagues. The premier gaming destination in the United States, FanDuel Group consists of a portfolio of leading brands across gaming, sports betting, daily fantasy sports, advance-deposit wagering, and TV/media, including FanDuel, Betfair US, and TVG. FanDuel Group has a presence across 45 states and 8.5 million customers. The company is based in New York with offices in California, New Jersey, Florida, Oregon, and Scotland. FanDuel Group is a subsidiary of Flutter Entertainment plc, a leading international sports betting and gaming operator and a constituent of the FTSE 100 index of the London Stock Exchange.
About MotorCity Casino
Located on Grand River Avenue at the Lodge Freeway (M-10), MotorCity Casino Hotel is the only locally-owned and operated casino in Detroit. Marian Ilitch became the sole owner of MotorCity Casino in 2005 and soon embarked on a $300 million expansion and renovation project which was completed in 2008. The entertainment complex is now comprised of an expansive gaming space, including a smoke-free gaming area, the FanDuel Sportsbook at MotorCity Casino, an award-winning 400-room ultra-comfortable high tech hotel and other amenities. For more information about MotorCity Casino Hotel, or to make a reservation, visit www.MotorCityCasinoHotel.com or call 1-866-STAY-MCC.
Contacts
FanDuel
Emily Bass
FILE – Cutout photos of people, including first responders and healthcare workers, sit in seats in Gillette Stadium before an NFL football game between the New England Patriots and the Buffalo Bills in Foxborough, Mass., in this Monday, Dec. 28, 2020, file photo. The NFL says 7,500 health care workers vaccinated for the coronavirus will be given free tickets to next month’s Super Bowl to be played in Tampa, Florida. NFL Commissioner Roger Goodell also said in a news release Friday that attendance at the Feb. 7 game would be limited to those workers and about 14,500 other fans.(AP Photo/Charles Krupa, File)
ST. PETERSBURG, Fla. (AP) — The NFL announced Friday that 7,500 health care workers vaccinated for the coronavirus will be given free tickets to next month’s Super Bowl to be played in Tampa, Florida.
NFL Commissioner Roger Goodell also said in a news release that attendance at the Feb. 7 game would be limited to those workers and about 14,500 other fans. Raymond James Stadium, home of the Tampa Bay Buccaneers, has a capacity of just under 66,000, according to its website.
Most of the health care workers who will get free game tickets will come from the Tampa Bay area and central Florida, Goodell said. But he added that all 32 NFL teams will choose some workers from their cities to attend the game.
“These dedicated health care workers continue to put their own lives at risk to serve others, and we owe them our ongoing gratitude,” Goodell said. “We hope in a small way that this initiative will inspire our country and recognize these true American heroes.”
There will also be what Goodell called “a variety of special moments” to honor health care workers in the stadium during the game and also on the television broadcast by CBS.
Tampa Mayor Jane Castor said the NFL’s decision is a perfect way to honor health care workers at such a high-profile event.
“Our country has endured to much over the last year and we can’t lose sight of those who worked day in and day out to keep us safe,” Castor said in the NFL release.
As with NFL games throughout the season, the Super Bowl will include mandatory wearing of masks, social distancing, touchless concession stands and controlled entry and exits. The NFL had about 1.2 million fans attend 116 games so far during the regular season and playoffs, Goodell said.
This Sunday’s two conference championships will determine which teams meet in the Super Bowl. Tampa Bay travels to face the Green Bay Packers in the NFC, while the defending champion Kansas City Chiefs host the Buffalo Bills in the AFC.
If Tampa Bay wins, the Buccaneers will be the first team ever to play in a Super Bowl on their home field.
— Associated Press