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BeiGene’s Brukinsa with Obinutuzumab Receives the EC’s Approval for the Treatment of Follicular Lymphoma

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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 Chandra

Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.

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