FDA grants accelerated approval to sonrotoclax (Beqalzi) for relapsed or refractory mantle cell lymphoma

On May 13, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL‑2 inhibitor, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.

Efficacy and safety were evaluated in the single‑arm, multicenter phase 1/2 study BGB‑11417‑201 (NCT05471843), which enrolled 103 adult patients with relapsed or refractory MCL previously treated with anti‑CD20‑based therapy and a BTK inhibitor. Efficacy was assessed by an independent review committee using Lugano criteria, with overall response rate (ORR) and duration of response (DOR) as primary endpoints. The ORR was 52% (95% CI: 42–62), with a median time to response of 1.9 months. Median DOR was 15.8 months (95% CI: 7.4, not estimable), at an estimated median follow‑up of 11.9 months.

Safety data from 115 patients with MCL showed that serious adverse reactions occurred in 37% of patients, most commonly pneumonia (10%). The prescribing information includes warnings and precautions for tumor lysis syndrome (TLS), serious infections, and neutropenia. To mitigate the risk of TLS, treatment initiation includes a four‑week dose ramp‑up phase, followed by a recommended maintenance dose of 320 mg taken orally once daily until disease progression or unacceptable toxicity.

The application was reviewed under Project Orbis, a framework of the FDA Oncology Center of Excellence that supports concurrent international review of oncology products. The review involved collaboration with the European Medicines Agency (EMA) as an official observer, while applications may still be under assessment by other regulatory authorities. The sonrotoclax application also received priority review, breakthrough therapy designation, and orphan drug designation.

Link: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications