Bristol Myers Squibb has recently announced that they have achieved three regulatory acceptances, with the U.S. FDA and Japan’s MHLW acknowledging applications for Breyanzi® (lisocabtagene maraleucel).
In the U.S., the FDA accepted two supplemental Biologics License Applications (sBLA) for Breyanzi, seeking expansion into new indications for adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) post-Bruton tyrosine kinase inhibitor (BTKi) treatment.
Both applications received Priority Review, with PDUFA goal dates set for May 23, 2024, for FL and May 31, 2024, for MCL.
Japan’s MHLW also accepted Breyanzi’s supplemental New Drug Application (sNDA) for relapsed or refractory FL.
In a release, Anne Kerber, M.D., Bristol Myers Squibb’s senior vice president and Head of Late Clinical Development for Hematology, Oncology, and Cell Therapy (HOCT), emphasized the company’s dedication to providing innovative treatment options for patients battling follicular lymphoma and mantle cell lymphoma.
Kerber highlighted the frequent cycles of remission and relapse experienced by these patients and underscored Breyanzi’s potential for long-lasting response.
She noted that the recent regulatory acceptances in both the U.S. and Japan align with Bristol Myers Squibb’s commitment to making their cutting-edge CAR T cell therapy accessible to as many eligible patients as possible.
The applications for Breyanzi in relapsed or refractory follicular lymphoma (FL) in the U.S. and Japan draw from the TRANSCEND FL study. Breyanzi exhibited substantial complete response rates in this study.
For relapsed or refractory mantle cell lymphoma (MCL) in the U.S., the application is grounded in results from the MCL cohort of the TRANSCEND NHL 001 study. Breyanzi demonstrated statistically significant and clinically meaningful responses in heavily pre-treated patients, with a majority achieving a complete response.
Both studies affirm Breyanzi’s consistent safety profile, reporting no new safety signals.
Source: Regulatory Applications Accepted in the U.S. 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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