What Was Approved?
On May 13, 2026, the U.S. Food and Drug Administration granted accelerated approval to Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma, or MCL, after at least two prior lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
Beqalzi is not approved as a general first-line treatment for mantle cell lymphoma.
How Does Beqalzi Work?
Beqalzi is a BCL-2 inhibitor.
BCL-2 is a protein that can help cancer cells survive. By inhibiting BCL-2, sonrotoclax is designed to promote death of susceptible lymphoma cells.
How Is Beqalzi Taken?
The recommended target dose is 320 mg by mouth once daily, but treatment begins with a 4-week dose ramp-up schedule.
The tablets should be taken with food and water and swallowed whole.
What Did the Clinical Trial Show?
FDA evaluated Beqalzi in a multicenter study involving 103 adults with previously treated relapsed or refractory MCL.
The overall response rate was 52%, and the median duration of response was 15.8 months at the time of analysis.
These results describe the study population and do not guarantee an individual patient response.
Why Was It Granted Accelerated Approval?
The approval was based on response rate and durability of response.
Because this was an accelerated approval, continued approval may depend on confirmation of clinical benefit in a future randomized trial.
What Are the Main Safety Concerns?
The FDA prescribing information includes important warnings for:
- Tumor lysis syndrome
- Serious infections
- Neutropenia
- Embryo-fetal toxicity
Because tumor lysis syndrome can be serious, patients require appropriate preventive measures and monitoring during the dose ramp-up period.
Are Drug Interactions Important?
Yes.
Beqalzi has important interactions with medications that affect CYP3A.
Some strong CYP3A inhibitors are contraindicated during treatment initiation and the ramp-up period, while other interacting medications may require avoidance or dose modification.
Patients should provide their oncology team and pharmacist with a complete medication and supplement list.
Bottom Line
Beqalzi (sonrotoclax) is a newly FDA-approved oral BCL-2 inhibitor for certain adults with relapsed or refractory mantle cell lymphoma who have already received at least two prior systemic treatments, including a BTK inhibitor.
The approval was accelerated, so confirmatory evidence is still required to verify clinical benefit.
Sources
- U.S. Food and Drug Administration (FDA) — FDA Grants Accelerated Approval to Sonrotoclax for Relapsed or Refractory Mantle Cell Lymphoma, May 13, 2026.
- U.S. Food and Drug Administration (FDA) — Beqalzi (sonrotoclax) Prescribing Information, May 2026.
- U.S. Food and Drug Administration (FDA) — Novel Drug Approvals for 2026.