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Bristol Myers Squibb Nabs FDA Accelerated Approval for Breyanzi in Follicular Lymphoma

NEW YORK – The US Food and Drug Administration on Wednesday granted accelerated approval to Bristol Myers Squibb's Breyanzi (lisocabtagene maraleucel) as a therapy for previously treated relapsed or refractory follicular lymphoma patients. 

The agency approved the autologous CD19-directed CAR T-cell therapy for this patient population based on the results of the Phase II TRANSCEND-FL clinical trial, which included follicular lymphoma patients who had received at least two prior lines of treatment, including an anti-CD20 antibody and an alkylating agent. 

After a median follow-up of 16.8 months, the overall response rate was 95.7 percent among 94 efficacy-evaluable patients. The median duration of response was not yet reached at the time of data cutoff. 

Breyanzi is already approved in the US, Japan, and Europe as second- or later-line treatment for certain large B-cell lymphoma patients. It is also approved in the US, Japan, Europe, Switzerland, the UK, and Canada for treating relapsed and refractory LBCL after two or more lines of systemic therapy. In March, the treatment also netted FDA accelerated approval for third- or later-line chronic lymphocytic leukemia or small lymphocytic leukemia. 

In January, BMS said it is also seeking Breyanzi's approval for the follicular lymphoma indication in Japan.