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MAY 13 2026
APPROVED · 79 DAYS AGO

BeOne Medicines Beqalzi (sonrotoclax) $ONC

for relapsed or refractory mantle cell lymphoma

NDA · Priority Review · Accelerated Approval

FDA granted accelerated approval to Beqalzi (sonrotoclax) for relapsed or refractory mantle cell lymphoma. The drug enters a category currently led by AbbVie's Venclexta (venetoclax); the differentiation is centered on BCL2 selectivity and the dosing profile.

About

Mantle cell lymphoma is a type of non-Hodgkin's lymphoma that originates in a specific area of the lymph nodes. Beqalzi (sonrotoclax) is a drug that inhibits BCL2, a protein that helps cancer cells survive. By blocking this survival signal, the drug may cause cancer cells to die, potentially offering a new treatment option for patients whose disease has returned or resisted prior therapies.

Pivotal trial

NCT06742996 Phase 3 recruiting NCT06742996

The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.

Source: ClinicalTrials.gov

Also in development