Overview
- The filing targets adults with relapsed or refractory mantle cell lymphoma after BTK inhibitor therapy and follows an FDA breakthrough therapy designation granted in October 2025.
- Evidence comes from the global single-arm, open-label BGB-11417-201 study of 125 patients with responses assessed by an independent review committee.
- The trial met its primary endpoint of overall response rate and showed favorable complete response, duration of response and progression-free survival metrics with manageable toxicity.
- Part 1 (n=22) established a recommended 320 mg once-daily dose after ramp-up, which was used in part 2 (n=103).
- BeOne plans to pursue Project Orbis participation and EMA filings, will present data at the 2025 ASH meeting, and has related NDAs under review by China’s NMPA for MCL and CLL/SLL.