CHMP Adopts Positive Opinion Recommending Approval of Bristol Myers Squibb’s Opdivo® (nivolumab) in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patient...
Bristol-Myers Squibb Company (BMY)
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Source: Business Wire
Recommendation based on results from CheckMate -901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate a survival benefit versus standard-of-care chemotherapy alone in cisplatin-eligible adults with unresectable or metastatic urothelial carcinomaIf approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EUA decision on the EU marketing authorization is expected by June 2024 PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review th
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News
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- U.S. Food and Drug Administration Accepts Bristol Myers Squibb's Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase) [Yahoo! Finance]Yahoo! Finance
- European Medicines Agency Validates Bristol Myers Squibb’s Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Adult Patients with Microsatellite...Business Wire
- U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase)Business Wire
BMY
Earnings
- 4/25/24 - Miss
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Sec Filings
- 5/3/24 - Form 4
- 4/25/24 - Form 10-Q
- 4/25/24 - Form 8-K
- BMY's page on the SEC website