The monthly briefing for the MCL community.

The U.S. Food and Drug Administration (FDA) approved a new drug, sonrotoclax (brand name Beqalzi), on May 13, 2026 for people with MCL whose disease has returned or stopped responding after at least two prior treatments.

Sonrotoclax works by blocking a protein (BCL-2) that helps cancer cells survive. In a clinical study of 103 patients who had already tried other therapies — including BTK inhibitors — about half saw their cancer shrink, and many responses lasted over a year.

The FDA's approval on April 2, 2026 covers patients whose disease has returned or stopped responding to prior treatments, including BTK inhibitors.

The decision is based on longer-term follow-up from the ZUMA-2 clinical trial, which showed that Tecartus can produce deep and durable remissions in patients with heavily pretreated MCL. In the study, the overall response rate was 91%, while 68% achieved a complete response — meaning no detectable lymphoma remained after treatment.

For the MCL community, this is a significant development because treatment options become more limited once the disease progresses after BTK inhibitors.

The FDA has launched a new pilot program that could change how clinical trials are reviewed — and an MCL trial has been chosen as one of the first to take part.

Instead of waiting months or years to review results at the end of each trial phase, the FDA will now be able to see key safety and effectiveness information as it is happening, using secure, real-time data systems. One of the two initial trials selected for the FDA pilot is the Phase 2 TrAVeRse trial in patients with treatment-naïve mantle cell lymphoma.

FDA leaders say this shift is long overdue. "For 60 years, we've been conducting clinical trials in the same way, where key data signals can take years to reach the FDA," the agency said when announcing the pilot.

"Hi, I'm Larry Fagan — one of the MCLA board members. I was diagnosed back in 2012. There is never a good time to receive a cancer diagnosis, but mid-June 2012 was just after I retired and my son graduated from college. So, 2012 started with two long-anticipated endings and ended with a totally unanticipated six months of cancer treatment…"

A Phase 2 clinical trial published in Blood on April 21, 2026 reports encouraging results for a combination of two targeted immunotherapies — mosunetuzumab and polatuzumab — in patients with relapsed or refractory MCL who have already been through several lines of treatment.

Across 42 patients, 88% responded to the regimen and 79% achieved a complete response, meaning no detectable cancer at the end of treatment.

For patients living with MCL, this is meaningful because it could add another line of therapy after BTK inhibitors and CAR-T, where options are still limited.

CancerCare is offering an hour-long webinar for patients and health professionals addressing several topics, including treatment options for newly diagnosed and relapsed patients, clinical trials, and emerging treatment options. Best for patients with a baseline understanding of MCL.

The Lymphoma Research Foundation (LRF) is offering an hour-long webinar for patients addressing several topics, including first-line treatment options, the role of biomarkers, and emerging treatments currently under investigation.

Over the coming months, the MCLA is planning to build its operational footprint. If you would like to get involved, please reach out by filling out our volunteer form. We are especially interested in hearing from community members with experience in fundraising, grant writing, web development, patient mentoring, and support group facilitation.