BeiGene’s Brukinsa Receive Positive Opinion from EU’s CHMP for the treatment of Follicular Lymphoma
Shots:
- The Positive opinion was based on P-II study (ROSEWOOD) evaluating Brukinsa+ obinutuzumab vs obinutuzumab alone in r/r Follicular Lymphoma patients (n=217)
- 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: BeiGene | Image: BeiGene
Related News:- BeiGene’s Brukinsa with Obinutuzumab Receives the EC’s Approval for the Treatment of Follicular Lymphoma
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Kritika is a content writer at PharmaShots. She is interested in covering recent innovations from the pharma & MedTech industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
