Bristol Myers Squibb Announces U.S. FDA Accelerated Approval of KRAZATI® (adagrasib) in Combination with Cetuximab for Adult Patients with Previously Treated KRAS G12C-Mutated Locally Adva...
Bristol-Myers Squibb Company (BMY)
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Source: Yahoo! Finance
pretreated patients with locally advanced or metastatic CRC harboring a KRAS G12C mutation Second FDA approval for KRAZATI - reinforcing its potential across tumor types PRINCETON, N.J., June 21, 2024 BUSINESS WIRE Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRAZATI ® (adagrasib) in combination with cetuximab as a targeted treatment option for adult patients with KRAS G12C -mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR) results. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. "CRC with a KRAS G12C mutation occurs in ap
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BMY
Earnings
- 4/25/24 - Miss
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Sec Filings
- 6/25/24 - Form 11-K
- 6/25/24 - Form 11-K
- 6/25/24 - Form 11-K
- BMY's page on the SEC website