FDA Approves Sonrotoclax for Patients With Relapsed/Refractory Mantle Cell Lymphoma
Clinical Summary:
- Based on results from the phase 2 BGB-11417-201 trial, the FDA has granted accelerated approval to sonrotoclax for heavily pretreated adult patients with relapsed or refractory mantle cell lymphoma.
- In this single-arm, multicenter study, sonrotoclax demonstrated clinically meaningful and durable response, with a safety profile consistent with BCL-2 inhibition.
- This approval provides a new targeted treatment option for patients with heavily pretreated mantle cell lymphoma, a population with limited therapeutic options following BTK inhibitor exposure.
On May 13, 2026, the US Food and Drug Administration (FDA) approved sonrotoclax (Beqalzi, BeOne Medicines USA) for adult patients with relapsed/refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. This approval was based on results from the BGB-11417-201 trial.
In this single-arm, multicenter trial, 103 patients who had previously received anti-CD20-based therapy and a BTK inhibitor received sonrotoclax. Primary end points included overall response rate (ORR) and duration of response, as assessed by an independent review committee.
At a median follow-up of 11.9 months, the ORR was 52% with a median time to response of 1.9 months. The median duration of response was 15.8 months. Serious adverse reactions were reported in 37% of patients and most frequently included pneumonia (10%).
The recommended dose of sonrotoclax begins with a 4-week dose ramp-up phase to mitigate the risk of tumor lysis syndrome, followed by 320 mg orally once daily, until disease progression or unacceptable toxicity. The prescribing information includes warnings and precautions for tumor lysis syndrome, serious infections, and neutropenia.
Source:
US Food and Drug Administration. FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma. Accessed on May 13, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma
