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BeOne Medicines Gets FDA Accelerated Approval for Lymphoma Drug

Provided by Dow Jones May 13, 2026, 6:00:00 PM

By Kelly Cloonan

BeOne Medicines received accelerated approval from the Food and Drug Administration for Beqalzi, a treatment aimed at certain lymphoma patients.

The oncology company said Wednesday the treatment got FDA approval for adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy.

The accelerated approval is supported by data from a Phase 1/2 study that showed the treatment had an overall response rate of 52%, the company said.

Continued approval for the indication depends on the results of a confirmatory trial that is underway, the company said.

Write to Kelly Cloonan at kelly.cloonan@wsj.com

(END) Dow Jones Newswires

May 13, 2026 14:00 ET (18:00 GMT)

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