U.S. Food and Drug Administration Approves Augtyro™ (repotrectinib), a Next-Generation Tyrosine Kinase Inhibitor (TKI), for the Treatment of Patients with NTRK-Positive Locally Advanced or...
Bristol-Myers Squibb Company (BMY)
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Source: Yahoo! Finance
This accelerated approval marks the second indication for Augtyro in the U.S. PRINCETON, N.J., June 13, 2024 BUSINESS WIRE Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of Augtyro™ (repotrectinib) for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. The approval is based on results from the Phase 1/2 TRIDENT-1 study, which evaluated Augtyro in adult patients with NTRK -positive solid tumors. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical b
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- 4/25/24 - Miss
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Sec Filings
- 6/18/24 - Form 8-K
- 5/9/24 - Form 8-K
- 5/3/24 - Form 4
- BMY's page on the SEC website