The FDA Has Granted Breakthrough Therapy Designation To BeOne Medicines' Sonrotoclax, An Investigational BCL2 Inhibitor, For Relapsed Or Refractory Mantle Cell Lymphoma
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- 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 is underway.
- 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.