Dr Phillips on the Significance of the FDA Approval of Sonrotoclax for R/R MCL

“[The FDA approval of sonrotoclax] is a big thing for the relapsed or refractory MCL [population]…. Although we’ve had quite a few approvals lately, [there are still more drugs needed in the post-BTK inhibitor setting], and sonrotoclax is another option.”

Tycel Phillips, MD, an associate professor in the Department of Hematology and Hematopoietic Cell Transplantation in the Division of Lymphoma at City of Hope, discussed the May 2026 FDA approval of sonrotoclax(Beqalzi) for patients with mantle cell lymphoma (MCL) who have already received at least 2 prior lines of therapy. He highlighted the significance of the approval and in which cases the treatment can be best used.

The approval was based on data from the phase 1/2 BGB-11417-201 trial (NCT05471843), which showed patients who were previously treated with an anti-CD20–based therapy and a BTK inhibitor (n = 103) achieved an overall response rate of 52% (95% CI, 42%-62%) with a median time to response of 1.9 months. Moreover, patients had a median duration of response of 15.8 months (95% CI, 7.4-not evaluable) at a median follow-up of 11.9 months. Among patients evaluated for safety (n = 115), serious adverse effects were experienced by 37%, with pneumonia (10%) being the most common.

Phillips began by pointing out how the approval is significant for the MCL treatment paradigm, specifically since the sonrotoclax is a new, non-BTK inhibitor treatment. For example, in patients with relapsed or refractory MCL who receive but then progress on pirtobrutinib (Jaypirca), stopping them from becoming eligible for CAR T-cell therapy, sonrotoclax may be a good option, he stated. Phillips also noted that the oral administration of sonrotoclax is beneficial to this patient population. Ultimately, considering the limited number of patients with MCL and difficulties regarding conducting clinical trials in this population, having access to an agent like sonrotoclax at this point in its development during the wait for the readout of a confirmatory trial is important, he said.