Bristol Myers granted FDA priority review for lung cancer therapy

• Bristol Myers Squibb (NYSE:BMY) announced Tuesday that the FDA accepted its New Drug Application (NDA) for repotrectinib, a tyrosine kinase inhibitor (TKI) for lung cancer, granting the priority review for its marketing application.
• The agency has assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 27, 2023, to finalize its decision.
• Repotrectinib targets ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). The New York-based pharma giant added it with its ~$4B acquisition of Turning Point Therapeutics in 2022.
• BMY’s NDA was based on results from its ongoing registrational TRIDENT-1 study, which indicated the effects of repotrectinib in TKI-naïve and TKI-pretreated patients in terms of the durability of benefit and response rates.

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