FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma

The FDA has granted accelerated approval to sonrotoclax (Beqalzi) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least 2 lines of systemic therapy, including a BTK inhibitor.¹

The approval was supported by data from the phase 1/2 BGB-11417-201 trial (NCT05471843), which showed that patients with relapsed/refractory MCL who were previously treated with an anti-CD20–based therapy and a BTK inhibitor (n = 103) experienced an overall response rate (ORR) of 52% (95% CI, 42%-62%) and a median time to response of 1.9 months. At a median follow-up of 11.9 months, the median duration of response was 15.8 months (95% CI, 7.4-not estimable).

Regarding safety (n = 115), serious adverse effects were reported in 37% of patients, with the most common being pneumonia (10%). The prescribing information for sonrotoclax includes warnings and precautions for tumor lysis syndrome (TLS), serious infections, and neutropenia.

Sonrotoclax dosing is recommended to begin with a 4-week ramp-up phase to reduce the risk of TLS risk, followed by 320 mg once per day until disease progression or unacceptable toxicity.

References

1. FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma. FDA. May 13, 2026. Accessed May 13, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma