BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. - BeiGene (NASDAQ:BGNE), Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE (LON:SSE): 688235), a global biotechnology company, has received accelerated approval from the U.S. Food and Drug Administration (FDA) for its drug BRUKINSA® (zanubrutinib) to be used in combination with obinutuzumab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after at least two prior systemic therapies. This marks BRUKINSA's fifth oncology indication in the U.S. and positions it as the first and only BTK inhibitor approved for this use.
The approval was granted based on the positive outcomes from the ROSEWOOD trial, which demonstrated a higher overall response rate (ORR) for the combination of BRUKINSA and obinutuzumab compared to obinutuzumab alone.
The study included 217 patients with R/R FL, showing an ORR of 69% in the combination arm versus 46% in the monotherapy arm. The treatment also exhibited durable responses with an 18-month landmark duration of response (DOR) of 69%.
Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory MAHOGANY trial, currently in progress. The application for R/R FL also received Fast Track Designation and Orphan Drug Designation by the FDA.
BRUKINSA's safety profile was consistent with prior studies, with serious adverse reactions reported in 35% of patients receiving the combination treatment. Permanent discontinuation due to adverse reactions occurred in 17% of patients.
Dr. Mehrdad Mobasher, Chief Medical Officer, Hematology at BeiGene, highlighted the significance of the approval, stating that BRUKINSA is the only BTK inhibitor to show efficacy for this type of malignancy and now has the broadest label within its class globally.
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