FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
Regulatory approval news: On May 13, 2026, the FDA granted accelerated approval to sonrotoclax (Beqalzi), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma after at least two prior systemic therapies, including a BTK inhibitor. Approval was supported by the single-arm BGB-11417-201 trial (NCT05471843), where overall response rate was 52% and median duration of response was 15.8 months per independent review.
FDA accelerated approval: sonrotoclax for relapsed/refractory mantle cell lymphoma
Type: Regulatory approval (accelerated approval)
Date: 2026-05-13
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 (MCL) after ≥2 lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
Supporting evidence
Efficacy was evaluated in BGB-11417-201 (NCT05471843), a single-arm, multicenter study in 103 adults with relapsed/refractory MCL previously treated with anti-CD20–based therapy and a BTK inhibitor. Endpoints supporting accelerated approval were overall response rate (ORR) and duration of response (DOR) assessed by an independent review committee using Lugano criteria.
- ORR: 52% (95% CI, 42–62)
- Median time to response: 1.9 months
- Median DOR: 15.8 months (95% CI, 7.4–not estimable)
- Estimated median follow-up: 11.9 months
Safety and dosing highlights
Label warnings/precautions include tumor lysis syndrome, serious infections, and neutropenia. Among 115 MCL patients evaluated for safety, serious adverse reactions occurred in 37%, most commonly pneumonia (10%).
The recommended regimen includes a 4-week ramp-up to reduce TLS risk, then 320 mg orally once daily until progression or unacceptable toxicity.
The FDA review was conducted under Project Orbis; applications may still be under review at other agencies.