Brukinsa(zanubrutinib)

Brukinsa (zanubrutinib) is a drug reviewed under NDA/BLA 213217, S-004, with a sNDA approval date of December 18, 2020. The application type was 505(b)(1) and received a Standard priority review. The drug's efficacy was evaluated, showing a complete response (CR) rate of 59%. The VGPR/CR rate was observed at 32.4% and 19.2%. The median follow-up time for duration of Overall response ranged from 22.3 to 23.9 months, with an event-free rate at 24 months of 82.2%.

Safety findings for Brukinsa (WM Cohort 1) included pyrexia at 16%, edema peripheral at 12%, bruising at 20%, and rash at 29%. For comparison, Ibrutinib (WM Cohort 1) showed fatigue at 25%, pyrexia at 13%, nausea at 13%, edema peripheral at 20%, bruising at 34%, and rash at 32%. A total of 662 patients were exposed to Brukinsa, with 74% exposed for at least 1 year and 55% for at least 2 years.