WASHINGTON, May 18, 2026—The U.S. Food and Drug Administration (FDA) has approved sonrotoclax (Beqalzi™) for use in adults with mantle cell lymphoma (MCL) that has failed to respond or has returned after two earlier treatments, including a Bruton’s tyrosine kinase (BTK) inhibitor (ibrutinib, acalabrutinib, zanubrutinib or pirtobrutinib are currently FDA approved for MCL).
Mantle cell lymphoma is a rare and aggressive blood cancer, and while many patients initially respond to treatment, the disease often returns.
“For people with mantle cell lymphoma whose disease has returned after a BTK inhibitor, this approval offers a much-needed new option and renewed hope at a point when treatment choices are limited,” said Lore Gruenbaum, Ph.D., Chief Scientific Officer of Blood Cancer United.
Accelerated approval gives patients earlier access to treatments
Sonrotoclax was approved under the FDA’s accelerated approval program, which provides earlier access to drugs that address serious and life-threatening conditions. Full approval for this indication is contingent upon confirmation of the drug's benefit in the ongoing CELESTIAL-RRMCL trial (NCT06742996).
The accelerated approval was based on results from a clinical trial that enrolled 103 adults with relapsed or refractory MCL. All participants had previously received anti-CD20-based therapy and a BTK inhibitor.
In the study, 52% of patients responded to treatment, with responses occurring relatively quickly — a median of just under 2 months after starting therapy. Among those whose disease responded, the median duration of response was 15.8 months.
“Sonrotoclax is the first FDA-approved BCL-2 inhibitor now available specifically for MCL. We celebrate the availability of new treatments that extend and improve the lives of patients and give hope to them and their families,” said Dr. Gruenbaum.
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