FDA approves Bristol Myers Squibb's Breyanzi for follicular lymphoma [Yahoo! Finance]
Bristol-Myers Squibb Company (BMY)
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Source: Yahoo! Finance
The CD19-directed chimeric antigen receptor (CAR) T cell therapy is indicated for patients who have undergone at least two previous systemic therapies. Administered as a one-time infusion, Breyanzi delivers a dose of 90 to 110 x 106 CAR-positive viable T cells to patients. The approval is based on results from the open-label, global, multicentre, single-arm Phase II TRANSCEND FL clinical trial evaluating Breyanzi's efficacy and safety. The primary outcome measure was overall response rate, while secondary measures included complete response rate, duration of response, progression-free survival and safety. The trial demonstrated an overall response rate of 95.7% while the complete response rate was 73.4%. Responses were reported to be quick, with a median time of one month, and durable. The median duration of response has not yet been reached. At 12 and 18 months, the majority remained in response. Breyanzi has shown a consistent safety profile throughout the trials. C
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News
- Bristol Myers Squibb's Breyanzi gains FDA approval for lymphoma [Yahoo! Finance]Yahoo! Finance
- Bristol Myers (BMY) Gets EC Nod for Opdivo Label Expansion [Yahoo! Finance]Yahoo! Finance
- LabCentral Ignite Launches Fourth Annual Golden Ticket Contest [Yahoo! Finance]Yahoo! Finance
- U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell LymphomaBusiness Wire
- Preliminary Clinical Data on Relma-Cel Injection in Adults with Active Systemic Lupus Erythematosus in China at the Eular 2024 Congress [Yahoo! Finance]Yahoo! Finance
BMY
Earnings
- 4/25/24 - Miss
BMY
Sec Filings
- 5/9/24 - Form 8-K
- 5/3/24 - Form 4
- 4/25/24 - Form 10-Q
- BMY's page on the SEC website