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

 ­ Ref: Businesswire | Image: BeiGene