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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