Beqalzi is the first BCL2 inhibitor approved for relapsed or refractory mantle cell lymphoma.
The FDA has cleared BeOne Medicines’ BCL2 blocker sonrotoclax for the treatment of certain patients with mantle cell lymphoma, an approval that opens a new approach to treating this malignancy. The drug will carry the brand name Beqalzi.
Beqalzi is specifically indicated for patients with relapsed or refractory mantle cell lymphoma (R/R MCL) who have undergone at least two prior lines of systemic therapy, including a BTK inhibitor, according to a Thursday news release. Beqalzi was approved under the FDA’s accelerated pathway and will need a confirmatory study to verify its clinical benefits to sustain the approval.
Beqalzi is the first BCL2 inhibitor indicated for this indication, BeOne said. The drug is also the company’s third commercial product, coming after the BTK inhibitor Brukinsa, which was cleared in November 2019 for MCL, and the PD-1 inhibitor Tevimbra, which the FDA first approved in March 2024 for esophageal cancer.
Despite these distinctions, however, analysts at Truist Securities called Beqalzi’s approval “incremental,” pointing to the “relatively small” market for R/R MCL. The firm forecasts around $300 to $400 million in sales for Beqalzi in this indication.
Phase 1/2 data supported the FDA’s decision on Thursday. The trial, a single-arm open-label study, enrolled 125 patients with R/R MCL. Results demonstrated a 52% overall response rate, including a 16% complete response rate, BeOne said. Median duration of response was 15.8 months.
BeOne is currently running the Phase 3 CELESTIAL-RRMCL study, which will serve as Beqalzi’s confirmatory trial. The study has a primary completion date of August 2028.
Beqalzi is a next-generation BCL2 inhibitor that works by triggering cancer cell death. BeOne is studying Beqalzi as part of a fixed-duration regimen with Beqvez for chronic lymphocytic leukemia. Truist has higher hopes for this market than MCL, with peak sales of over $3.4 billion projected, according to the firm’s Thursday note.
While incremental on a market-level, Beqalzi’s approval is nevertheless good news for BeOne, which at the 2026 American Association for Cancer Research annual meeting in April presented underwhelming data. A Phase 2 readout at the conference showed that several combination regimens based on Tevimbra—including with the TIM-3 blocker surzebiclimab and the anti-LAG-3 therapy alcestobart—elicited no significant efficacy improvement over monotherapy in recurrent and/or metastatic head and neck squamous cell carcinoma.
