BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Accelerated Approval for Patients with Mantle Cell Lymphoma Who Received At least One Prior Therapy

BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Accelerated Approval for Patients with Mantle Cell Lymphoma Who Received At least One Prior Therapy

Shots:

  • The US FDA’s accelerated approval is based on P-II BGB-3111-206 and P-I/II BGB-3111-AU-003 studies assessing Brukinsa in patients with relapsed or refractory (R/R) MCL
  • The P-II BGB-3111-206 & P-I/II BGB-3111-AU-003 studies result: ORR (84% & 84%); CR (59% & 22%, FDG-PET scan required & not required); PR (24% & 62%); DOR (19.5 & 18.5 mos.); median follow up time (18.4 & 18.8 mos.)
  • Brukinsa (320mg, PO) is the only FDA approved BTK inhibitor that showed 100% median occupancy in peripheral blood cells and the only BTK inhibitor with the flexibility to be taken once or twice daily with its anticipated availability in the US in the coming wks.

Click here to­ read full press release/ article | Ref: BeiGene | Image: The Standard