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MAY 13 2026
APPROVED · 21 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 rare and aggressive form of non-Hodgkin’s lymphoma that originates in the lymph nodes. Beqalzi (sonrotoclax) is a BCL2 inhibitor that blocks a protein cancer cells rely on to survive, effectively starving them of their survival mechanism. By targeting this critical pathway, Beqalzi may help slow the progression of relapsed or refractory mantle cell lymphoma in patients who have exhausted other treatment options.

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