US FDA Accepts for Priority Review Bristol Myers Squibb's Application for Opdivo (Nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic
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The US FDA has accepted Bristol Myers Squibb's sBLA for Opdivo in combination with cisplatin-based chemotherapy for first-line treatment of unresectable or metastatic urothelial carcinoma. The application has been granted Priority Review with a PDUFA goal date of April 5, 2024.
December 05, 2023 | 12:00 pm
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Bristol Myers Squibb's sBLA for Opdivo has been accepted by the FDA for Priority Review, which could lead to faster approval and market access for the treatment.
The acceptance of the sBLA for Priority Review by the FDA is a positive development for Bristol Myers Squibb, indicating that the treatment could be of significant benefit to patients and may reach the market sooner than standard reviews. This could potentially boost the company's revenue and market position in oncology treatments, positively impacting the stock price in the short term.
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