BeiGene’s Brukinsa with Obinutuzumab Receives the EC’s Approval for the Treatment of Follicular Lymphoma
Shots:
- The approval was based on the data from the P-II (ROSEWOOD) clinical trial evaluating Brukinsa + Obinutuzumab vs Obinutuzumab alone in patients (n=217) with r/r follicular lymphoma
- The results from the study depicted an ORR of 69% vs 45.8% with a median follow-up of ~20mos. whereas DoR was found to be 69.3% in patients being treated with the combination therapy & mPFS was 28.0mos. vs 10.4mos.
- Brukinsa, a BTK inhibitor, has been approved as a monotx. in the EU & the company has planned submissions for the regulatory review of Brukinsa by the US FDA & NMPA. Moreover, the applications for Brukinsa are under review by the regulatory authorities of Canada, Switzerland & the UK
Ref: Businesswire | Image: BeiGene
Related News:- BeiGene’s Brukinsa (zanubrutinib) Receives the NICE Recommendation for Adult Patients with Chronic Lymphocytic Leukemia
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
