SAN CARLOS, CALIF. -- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). Additionally, the FDA has accepted BeOne’s request for participation in Project Orbis, an initiative that provides a framework for concurrent submission and review of oncology products among participating global health authorities.

“Breakthrough Therapy Designation is reserved for medicines with the potential to transform outcomes for patients with serious diseases. This recognition affirms the strength of the emerging data for sonrotoclax and its potential to become a new standard of care for people with relapsed or refractory mantle cell lymphoma,” said Julie Lepin, Senior Vice President, Chief Regulatory Affairs Officer at BeOne. “Additionally, by participating in Project Orbis, we may be able to accelerate access to sonrotoclax, potentially helping patients faster than previously imagined.”

The decision by the FDA to grant sonrotoclax BTD and participation in Project Orbis was based on data from the BGB-11417-201 study, a Phase 1/2 study evaluating sonrotoclax in adult patients with R/R MCL, following treatment with a Bruton’s tyrosine kinase inhibitor (BTKi) and anti-CD20 therapy. The recently announced positive topline results for sonrotoclax underscore its potential to deliver deep and durable responses, giving it the potential to be the first and only BCL2 inhibitor approved for use in R/R MCL in the U.S. BeOne plans to present the full data at an upcoming medical meeting. The Phase 3 confirmatory CELESTIAL-RRMCL study (BGB-11417-302; NCT06742996) is underway.

The FDA grants BTD to medicines with early data suggesting they may offer significant advances for patients with serious diseases. Project Orbis, established by the FDA Oncology Center of Excellence in 2019, facilitates collaboration across regulatory bodies on the review of oncology medicines with the goal of making promising cancer therapies available to patients more quickly across participating countries.

This is the first BTD for sonrotoclax and the second for BeOne’s hematology program. The FDA has also granted sonrotoclax Fast Track Designation for MCL and Waldenström macroglobulinemia (WM), as well as Orphan Drug Designation for the treatment of adult patients with MCL, WM, multiple myeloma (MM), and acute myeloid leukemia (AML). These designations help reinforce sonrotoclax’s position as the next major advancement in BeOne’s commitment to redefining care in B-cell malignancies.