On May 13, 2026, the FDA approved sonrotoclax (Beqalzi from BeOne), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL). It is approved for use after two lines of therapy, including anti-CD20-based therapy and a BTK inhibitor.
In terms of background, MCL is a more aggressive B-cell lymphoma that is closely related to chronic lymphocytic leukemia / small cell lymphoma (CLL / SLL). Sometimes, there can even be confusion in the diagnosis as the two diseases share many similar characteristics. Because MCL patients often progress faster than those with CLL, there is a long history of medications being first approved for MCL, and later for CLL. One example is ibrutinib.
While there are many BTK inhibitors approved, there has been only one available BCL-2 inhibitor, venetoclax. The approval of sonrotoclax now offers a second option for MCL patients.
Why should CLL patients care about an MCL drug approval?
Because in the USA, any drug can be used “off label”, so sonrotoclax, now theoretically, could be prescribed for CLL / SLL and other lymphomas if deemed clinically appropriate. This is, in fact, how some of the first CLL patients accessed ibrutinib more than a decade ago, well before it was approved for their disease.
Whether insurance would pay for it is a whole different question. Generally, once NCCN guidelines include a medication as one of its treatment options, it is covered, even if it is not yet FDA-approved. Not surprisingly, sonrotoclax is not yet part of the NCCN CLL guidelines. Sometimes, a medication will be paid for even without the help of the NCCN guidelines if there is enough clinical data to argue that it is a good option for a specific patient. But argue might be the operative word, as it can be a difficult and lengthy struggle for the prescribing physician and the patient to get the payor to cover the cost of the drug.
There are ongoing trials that should lead to sonrotoclax’s approval in CLL / SLL (it is already approved in China), including CELESTIAL-TNCLL (BGB-11417-301, NCT06073821) — Treatment-Naïve CLL. CLL Society has reported on earlier trial results and will continue as there will be updates at the upcoming cancer and hematology meetings that may help bolster the evidence needed to help CLL patients access it “off label”.
Sonrotoclax, similar to venetoclax, needs to be ramped up slowly to prevent tumor lysis syndrome (TLS), but its long four-week ramp up, greater potency, and shorter half-life may make it less of an issue for patients. Also, like venetoclax, its label includes potential side effects, including TLS, serious infections, and neutropenia (low neutrophil count).
The FDA link shares the results from the MCL trial that led to its approval, including its efficacy in difficult-to-treat relapsed or refractory patients and its side effects. More details can be found at FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma.
While this is not practice-changing news for many CLL / SLL patients today, it is a positive step forward towards having another strong treatment option, hopefully in the not-too-distant future.
