BeiGene’s Brukinsa Receives the US FDA’s Accelerated Approval for the Treatment of Follicular Lymphoma (FL)
Shots:
- The company received the US FDA’s accelerated approval for Brukinsa (zanubrutinib) + obinutuzumab (anti-CD20 mAb) as a treatment for adult patients with r/r FL
- Earlier, Brukinsa received the US FDA’s accelerated approval based on the ORR data from the P-II (ROSEWOOD) clinical trial evaluating the safety & efficacy of Brukinsa + obinutuzumab vs obinutuzumab alone in patients (n=217) with r/r FL who received two prior lines of systemic therapy. The results from the study depicted an ORR of 69% vs 46% at 20mos. follow-up & 69% DoR with the combination therapy
- Brukinsa’s continued approval may be validated by the results from the confirmatory P-III (MAHOGANY) trial. Additionally, Brukinsa received the US FDA’s FTD & ODD
Ref: Businesswire | Image: BeiGene
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
