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

September 15, 2021 Auto Bot BeiGene, FDA, regulatory 0

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

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