China-based biotechnology leader BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced the receipt of a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending approval for its BTK inhibitor Brukinsa (zanubrutinib) as a treatment for relapsed/refractory follicular lymphoma (r/r FL). This recommendation positions Brukinsa as a potential third-line treatment for FL, with a full decision from the European Commission (EC) expected within 67 days.
CHMP Recommendation and Clinical Data
The CHMP based its positive recommendation on data from the ROSEWOOD study, further supported by the BGB-3111-GA101-001 study. The pivotal ROSEWOOD study (NCT03332017), an ongoing global Phase II trial, evaluated the efficacy of Brukinsa in combination with obinutuzumab in 217 patients with R/R FL in the third-line setting. The study demonstrated an overall response rate (ORR) of 69.0% for the combination therapy versus 45.8% for obinutuzumab alone (p = 0.0012), with a median follow-up of approximately 20 months, indicating significant therapeutic benefits.
Global Approval and Market Presence
Brukinsa has already secured approval for various indications in 65 markets worldwide. Within the European Union, the drug is approved for use as monotherapy in adults with chronic lymphocytic leukemia, marginal zone lymphoma, and Waldenström’s macroglobulinemia. BeiGene is also eagerly awaiting approval decisions for the r/r FL indication in both China and the United States, further expanding the drug’s global impact and accessibility.-Fineline Info & Tech
