FDA Approves Expanded Use Of Bristol Myers Squibb's Breyanzi Cancer Cell Therapy For Previously Treated Follicular Lymphoma
Portfolio Pulse from Vandana Singh
The FDA has granted accelerated approval to Bristol Myers Squibb's Breyanzi for the treatment of relapsed or refractory follicular lymphoma. This approval is based on response rate and duration of response, with continued approval contingent on further clinical trials. The FDA has also mandated boxed warnings for all CAR T-cell therapies. Breyanzi is now included in the NCCN Guidelines for B-cell Lymphomas and showed a high response rate in clinical trials.
May 16, 2024 | 3:56 pm
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The FDA has granted accelerated approval to Bristol Myers Squibb's Breyanzi for relapsed or refractory follicular lymphoma. This approval is based on response rate and duration of response, with continued approval contingent on further clinical trials. The FDA has also mandated boxed warnings for all CAR T-cell therapies. Breyanzi is now included in the NCCN Guidelines for B-cell Lymphomas and showed a high response rate in clinical trials.
The FDA's accelerated approval of Breyanzi for a new indication is a positive development for Bristol Myers Squibb, potentially leading to increased sales and market share. The inclusion in NCCN Guidelines further validates the therapy's efficacy. However, the requirement for boxed warnings may temper some of the enthusiasm.
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