Logo

BeiGene’s Brukinsa Receives the US FDA’s Accelerated Approval for the Treatment of Follicular Lymphoma (FL)

Share this
BeiGene

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

Related News:- BeiGene Reports Results from a Comparative Analysis of Brukinsa vs Acalabrutinib for the Treatment of Chronic Lymphocytic Leukemia (CLL)

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

Click here to­ read the full press release 

Disha Nankani

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.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions