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Endpoints·May 14·1 min read
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BeOne Medicines receives accelerated FDA approval for sonrotoclax in mantle cell lymphoma

May 14, 2026·read at Endpoints ↗ApprovalPositive

BeOne Medicines announced that the U.S. Food and Drug Administration granted accelerated approval to its BCL2 inhibitor sonrotoclax for treatment of mantle cell lymphoma.

The approval is based on early clinical data showing activity in this rare blood cancer, positioning sonrotoclax as a potential competitor to AbbVie and Roche’s Venclexta.

This decision marks the first regulatory clearance for the next-generation BCL2 inhibitor and opens the path for BeOne to pursue additional indications in other blood cancers.

Investors and analysts view the milestone as a significant step for BeOne, potentially expanding its market presence in the oncology sector.

source

This writeup was produced by pharmadog from original reporting by Endpoints.

Original headline: “BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta”

read at Endpoints ↗
85 words · retrieved May 14
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companies & drugs in this story

companies
ABBVIE2BeOne Medicines Ltd.2ROCHE2PATHUltragenyx Pharmaceutical Inc.
drugs
VENCLEXTA3sonrotoclax3venetoclax3
topics
Approval5Hematology3Oncology2Rare Disease

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