Beigene receives its first FDA approval for a MCL drug
The accelerated approval was based upon overall response rate (ORR) results from two single-arm trial; ORR data was assessed by an independent review committee. Continued approval of Brukinsa is contingent on a confirmatory trial. In a Phase II trial, 84% of patients receiving Brukinsa achieved ORR, with 59% having a complete response and 24% a partial response. Median duration of response was 19.5 months, and there was an 18.4 month median follow-up time. Similar results were observed in a Phase I/II study; there was an 84% ORR, a 22% complete response rate and a 62% partial response rate, while median response duration was 18.5 months and study follow-up was 18.8 months. Beigene CEO, co-founder and chairman John Oyler said: “Today’s FDA approval of Brukinsa, following the previously granted Breakthrough Therapy designation in this indication, validates it as an important treatment option for people with relapsed or refractory MCL.