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BeOne Medicines Gets FDA Approval for Brukinsa Tablet in Blood Cancer Indications
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BeOne Medicines Gets FDA Approval for Brukinsa Tablet in Blood Cancer Indications
Jun 11, 2025 3:12 PM

04:43 PM EDT, 06/11/2025 (MT Newswires) -- BeOne Medicines (ONC) said late Wednesday that the US Food and Drug Administration approved a new tablet formulation of Brukinsa for all currently approved indications.

Brukinsa is used to treat chronic or small lymphocytic leukemia, Waldenstrom's macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma.

The new 160-milligram tablets have the same efficacy and safety as the existing capsules, based on two phase 1 bioequivalence studies.

BeOne said the new tablets are smaller, film-coated, and require fewer pills per day, simplifying dosing for patients. The tablets will begin replacing capsules starting in October.

The European Medicines Agency is currently reviewing a type 2 variation application for the tablet formulation, with approval expected later this year, according to the company.

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