Regulatory Applications Accepted in the US and Japan for Bristol Myers Squibb's Breyanzi (Lisocabtagene Maraleucel) in Relapsed or Refractory Follicular Lymphoma (FL) and Relapsed or Refractory Mantle Cell Lymphoma (MCL)
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Bristol Myers Squibb (NYSE:BMY) announced the FDA's acceptance of two sBLAs for Breyanzi to treat relapsed or refractory FL and MCL, granting Priority Review with PDUFA goal dates in May 2024. Japan's MHLW also accepted an sNDA for Breyanzi for relapsed or refractory FL.
January 30, 2024 | 12:00 pm
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Bristol Myers Squibb's Breyanzi received FDA Priority Review for treating FL and MCL, with PDUFA dates in May 2024. Japan's MHLW also accepted Breyanzi's sNDA for FL treatment.
The acceptance of Breyanzi's sBLAs by the FDA and the sNDA by Japan's MHLW is a positive development for Bristol Myers Squibb, indicating progress in expanding the treatment's indications. The Priority Review status in the US could lead to a faster approval process, which is likely to be viewed favorably by investors. The PDUFA goal dates provide a clear timeline for potential market expansion, which could positively impact the stock price in the short term.
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