← Back to The Docket MAY 13 2026
APPROVED · 79 DAYS AGO
— 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
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