Bristol Myers’ application for Breyanzi in lymphoma accepted in U.S. and Japan

Bristol Myers announced three regulatory acceptances from the FDA and Japan’s Ministry of Health, Labour and Welfare – MHLW – for Breyanzi. In the U.S., the FDA has accepted the company’s two supplemental Biologics License Applications for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma and relapsed or refractory mantle cell lymphoma after a Bruton tyrosine kinase inhibitor. The FDA has granted both applications Priority Review and assigned a Prescription Drug User Fee Act goal date of May 23 for Breyanzi in relapsed or refractory FL and May 31 for Breyanzi in relapsed or refractory MCL. Japan’s MHLW has also accepted Bristol Myers Squibb’s supplemental New Drug Application for Breyanzi for the treatment of relapsed or refractory FL. In relapsed or refractory FL, the applications for Breyanzi in the U.S. and Japan are based on results from the TRANSCEND FL study.In the study, Breyanzi demonstrated high rates of complete responses. In relapsed or refractory MCL, the application for Breyanzi in the U.S. is based on results from the MCL cohort of the TRANSCEND NHL 001 study, in which Breyanzi demonstrated statistically significant and clinically meaningful responses in heavily pre-treated patients, with the majority of patients achieving a complete response. A sBLA for Breyanzi for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received a prior BTKi and B-cell lymphoma 2 inhibitor is also currently under Priority Review with the FDA with an assigned target action date of March 14.