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# FDA Awards Breakthrough Status to Lymphoma Drug
- URL: https://www.fdaweb.com/fda-awards-breakthrough-status-to-lymphoma-drug/
- Published: 2025-10-13T12:00:00.000Z
- Updated: 2026-09-14T15:23:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160031

FDA has granted BeOne Medicines a breakthrough therapy designation for sonrotoclax and its use in treating adults with relapsed or refractory mantle cell lymphoma (MCL). The designation is based on positive data from a Phase 1-2 clinical study (BGB-11417-201) evaluating sonrotoclax in patients with MCL who had previously received both Bruton’s tyrosine kinase inhibitor and anti-CD20 therapy. The agency also accepted BeOne’s request to include the investigational drug in Project Orbis, an international regulatory collaboration that supports simultaneous review of oncology medicines among participating countries.

BeOne says it will present full results from the study at an upcoming medical meeting. The company has also launched a Phase 3 confirmatory trial, CELESTIAL-RRMCL (NCT06742996), to further evaluate sonrotoclax in the patient population.

Sonrotoclax is described as a next-generation, investigational BCL2 inhibitor designed to promote cancer cell death by blocking proteins that help malignant cells survive. If approved, it could become the first BCL2 inhibitor available for relapsed or refractory mantle cell lymphoma in the U.S.