Shots:
- The approval is based on efficacy results from two studies. The P-II BGB-3111-206 study evaluates zanubrutinib in patients with R/R MCL and showed ORR (84%), CR (69%), PR (15%), mDoR (19.5mos.) @median follow-up time of 18.5mos.
- The P-I/II BGB-3111-AU-003 study showed ORR (84%) including CR (25%) & PRs (59%), m-DoR (18.5mos.) @ median follow-up time of 18.8mos. The recommended dose of Brukinsa is either 160mg bid or 320mg, qd, taken orally with/out food
- The approval marks the second approval of Brukinsa in Canada, following its initial approval in March 2021 for adult patients with WM
Click here to read full press release/ article | Ref: Businesswire | Image: BeiGene
The post BeiGene’s Brukinsa (Zanubrutinib) Receives Health Canada’s Approval for Mantle Cell Lymphoma first appeared on PharmaShots.
