FDA Approval

FDA Grants Accelerated Approval to Sonrotoclax (Beqalzi) for Relapsed or Refractory MCL

Edited by:
Ashton L. Stahl

Key Highlights

  • Sonrotoclax received accelerated approval for adults with relapsed or refractory mantle cell lymphoma after at least 2 prior systemic therapies.
  • Efficacy was based on a 52% overall response rate in a single-arm, multicenter trial.
  • Prescribing information includes warnings for tumor lysis syndrome, serious infections, and neutropenia.

The FDA granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma after at least 2 lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor, according to a May 13, 2026, FDA press release.

The approval was supported by BGB-11417-201 (NCT05471843), a single-arm, multicenter trial that evaluated efficacy in 103 adults with relapsed or refractory mantle cell lymphoma. Patients had previously received anti-CD20-based therapy and a BTK inhibitor.

Study Findings

Efficacy was established based on overall response rate and duration of response, as assessed by an independent review committee using the Lugano criteria. The overall response rate was 52% (95% CI, 42-62), and the median time to response was 1.9 months.

After an estimated median follow-up of 11.9 months, the median duration of response was 15.8 months (95% CI, 7.4-not estimable). Among 115 patients with mantle cell lymphoma evaluated for safety, 37% experienced serious adverse reactions. Pneumonia was the most frequent serious adverse reaction, occurring in 10% of patients.

Recommended Regimen

The recommended sonrotoclax regimen begins with a 4-week ramp-up phase to reduce the risk of tumor lysis syndrome, followed by 320 mg taken orally once daily until disease progression or unacceptable toxicity. The prescribing information includes warnings and precautions for tumor lysis syndrome, serious infections, and neutropenia.

The review was conducted under Project Orbis, an FDA Oncology Center of Excellence initiative for concurrent submission and review of oncology drugs among international partners. The FDA collaborated with the European Medicines Agency as an official observer; applications may still be under review at other regulatory agencies.

Regulatory Designations and Reporting

The application received priority review, breakthrough designation, and orphan drug designation. Health care professionals should report serious adverse events suspected of being associated with medicines or devices to the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

Reference

US Food and Drug Administration. FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma. FDA. Published May 13, 2026. Accessed May 14, 2026. (fda.gov)