BeOne赢得FDA加速批准Beqalzi治疗淋巴瘤

2026-05-14 02:03

BeOne Medicines (ONC) announced on Wednesday that the U.S. Food and Drug Administration granted accelerated approval for its lymphoma therapy, Beqalzi, pending the outcome of an ongoing, confirmatory study.
The approval allows the Switzerland-based firm to market the B-cell lymphoma 2 inhibitor as a late-line option to treat adults with relapsed or refractory mantle cell lymphoma, a rare form of non-Hodgkin lymphoma.
The decision paves the way for the market entry of the first BCL2 inhibitor approved in the U.S. in a decade and the only BCL2 inhibitor cleared to treat mantle cell lymphoma. The aggressive cancer type is newly diagnosed in about 3,300 Americans each year.
The continued approval of Beqalzi is subject to positive data from the company’s confirmatory trial CELESTIAL-RRMCL. The Phase 3 trial is currently underway internationally, targeting adults with R/R MCL.

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