Oncology company BeOne Medicines Ltd (NASDAQ:ONC) (HKEX:06160) (SSE:688235) announced on Monday that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for sonrotoclax, its investigational BCL2 inhibitor, for adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

The FDA also accepted BeOne's request to participate in Project Orbis, enabling coordinated review of oncology products across multiple regulatory agencies.

The designation is based on positive topline results from the Phase 1/2 BGB-11417-201 study, which evaluated sonrotoclax in patients previously treated with Bruton's tyrosine kinase inhibitors and anti-CD20 therapy. BeOne plans to present the full study data at an upcoming medical meeting, and the Phase 3 CELESTIAL-RRMCL study (BGB-11417-302) is already underway.

Sonrotoclax has also received Fast Track Designation for MCL and Waldenström macroglobulinemia (WM), and Orphan Drug Designation for MCL, WM, multiple myeloma (MM), and acute myeloid leukaemia (AML).

Sonrotoclax has the potential to be the first and only BCL2 inhibitor approved for use in R/R MCL in the United States.