Phase 2/3 primary endpoint met, NDA under RTOR — darovasertib approval would create first-ever systemic standard of care in uveal melanoma

IDEAYA Biosciences is a clinical-stage biopharmaceutical company developing darovasertib, a targeted cancer drug for metastatic uveal melanoma, which is not yet approved.

Darovasertib plus crizotinib met its Phase 2/3 primary endpoint in first-line HLA-A*02:01-negative metastatic uveal melanoma, reducing progression risk by 58% versus control, and the NDA is now filed under Real-Time Oncology Review. The thesis resolves on whether FDA grants approval on single-arm-supported Phase 2/3 data in a rare cancer with no approved systemic standard of care. Immunocore's tebentafusp addresses only HLA-A*02:01-positive patients, a complementary rather than overlapping population, while IDE849's 80% ORR in SCLC represents a credible but unproven secondary engine.