BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of R/R Marginal Zone Lymphoma

 BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of R/R Marginal Zone Lymphoma

BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Accelerated Approval for the Treatment of R/R Marginal Zone Lymphoma

Shots:

  • The approval is based on 2 trials i.e., P-II MAGNOLIA & P-I/II BGB-3111-AU-003 trial evaluate Brukinsa (160mg, bid or 320 mg, qd) in 66 & 20 patients with R/R MZL who received at least 1 anti-CD20-based regimen
  • Both trial demonstrated ORR (56% & 80%), CR rate (20% & 20%) based on assessment using CT scan, m-DoR (not yet reached) @median follow-up (8.3 & 31.4mos.), 85% & 72% of responders still in remission @12mos. Based on assessment prioritizing PET-CT scan, ORR (67%), CR rate (26%) in MAGNOLIA trial
  • The therapy marks 3rd FDA approval in the US & is currently being evaluated in multiple studies globally as a monothx. or in combination with other therapies for multiple B cell malignancies

Click here to­ read full press release/ article | Ref: Businesswire | Image: Businesswire

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post