04:12 AM EDT, 05/16/2024 (MT Newswires) -- Bristol-Myers Squibb Company ( BMY ) said late Wednesday that the US Food and Drug Administration has granted accelerated approval for the company's cancer cell therapy, Breyanzi, intended to treat adults with follicular lymphoma, a type of blood cancer, who have received two or more prior lines of systemic therapy.

The approval is based on a phase 2 study which showed that patients treated with therapy had an overall response rate of 95.7%. Additionally, Breyanzi provided sustained clinical benefit, with a median duration of response not reached and 77.1% of responders remaining in response at 18 months.

Breyanzi, which is delivered as a one-time infusion, comes with a boxed warning like cytokine release syndrome, neurologic toxicities and secondary haematological malignancies.

The company said the therapy's continued approval would be based on verification of its clinical benefits in a confirmatory trial.

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