03:46 AM EDT, 03/15/2024 (MT Newswires) -- Bristol-Myers Squibb ( BMY ) said late Thursday the US Food and Drug Administration granted accelerated approval for its Breyanzi therapy for the treatment of patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
The drug maker said the accelerated approval is based on response rate and duration of response, while continued approval is subject to verification and description of clinical benefit in confirmatory trials.
In the company's phase 1/2 study for the product, 20% of patients treated with Breyanzi achieved a complete response, with median duration of response not reached among those patients at the time of data cutoff, the company said.
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