BeOne Medicines Ltd. announced that the U.S. Food and Drug Administration has accepted and granted Priority Review to its New Drug Application for sonrotoclax, a next‑generation BCL‑2 inhibitor, for adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL).
The priority review follows presentation of Phase 1/2 data from the BGB‑11417‑201 study, which enrolled 125 adults who had previously received a Bruton’s tyrosine kinase (BTK) inhibitor. The study met its primary endpoint of overall response rate (ORR) and reported a 55% ORR, a 30% complete response (CR) rate, a median duration of response (DOR) of 12 months, and a median progression‑free survival (PFS) of 9 months. Common adverse events were neutropenia, anemia, and nausea, all manageable with dose adjustments.
If approved, sonrotoclax would become the first BCL‑2 inhibitor approved in the U.S. for R/R MCL, a disease with limited options after BTK inhibitor failure. The U.S. market for R/R MCL is estimated at $1.2 billion annually, and sonrotoclax could capture a significant share by offering a novel mechanism of action and a favorable safety profile.
Global Head of R&D Lai Wang said the rapid progression from Breakthrough Therapy Designation to Priority Review demonstrates the strength of the data and the urgency of the unmet need. He added that sonrotoclax complements BeOne’s existing BTK inhibitor BRUKINSA and the investigational BTK degrader BGB‑16673, positioning the company as a leader in targeted therapies for hematologic malignancies.
Analysts highlighted the accelerated review timeline as a key driver of the positive market reaction. The announcement also coincides with BeOne’s plan to present full Phase 1/2 results at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando on December 7, and its participation in Project Orbis, which seeks concurrent review with international partners to speed global access.
The priority review is expected to shorten the FDA’s assessment to six months, potentially bringing sonrotoclax to patients earlier than the standard 10‑month review. The company’s pipeline momentum, combined with the strong performance of BRUKINSA, reinforces its growth trajectory and supports its first‑time profitability in Q3 2025.
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