BeOne Medicines (SS:688235) announced FDA accelerated approval of its BCL‑2 inhibitor Beqalzi for relapsed/refractory mantle cell lymphoma.
The drug showed a 16% complete response rate in an early‑to‑mid‑stage study, the first BCL‑2 inhibitor approved for this indication.
Beqalzi is slated for market launch in the second half of 2026, targeting roughly 3,300 new US mantle cell lymphoma cases annually.