FDA Accepts Ono Pharmaceutical's Tirabrutinib NDA for Review in Relapsed or Refractory PCNSL

ONO Pharmaceutical Co. Ltd. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for tirabrutinib, a Bruton's tyrosine kinase inhibitor, for the treatment of relapsed or refractory primary central nervous system lymphoma (R/R PCNSL). The application will be reviewed under the accelerated approval pathway, with a Prescription Drug User Fee Act (PDUFA) action date set for December 18, 2026. The NDA is based on positive Phase 2 PROSPECT study results, and a global Phase 3 trial is ongoing as a confirmatory study.

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