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StocksMediumUpdated•Originally published 30 April 2026•Updated 1 May 2026•

1 min read

IDEAYA Biosciences to Initiate FDA Submission for Darovasertib via RTOR Program

Key Facts

1The U.S. FDA agreed to review the NDA for darovasertib combination under the Real-Time Oncology Review (RTOR) program.

2The Phase 2/3 OptimUM-02 registrational trial of darovasertib combination met its primary endpoint.

about 1 month ago

Version History

Version 1about 1 month ago

What changed: Specified the combination therapy (darovasertib with crizotinib), the specific patient population (HLA*A2-negative), and clarified that the primary endpoint met was progression-free survival.

IDEAYA Biosciences has initiated the New Drug Application (NDA) process for darovasertib in combination with crizotinib following FDA agreement to utilize the Real-Time Oncology Review (RTOR) program. The submission specifically targets first-line HLA*A2-negative metastatic uveal melanoma (mUM) patients. Topline data from the Phase 2/3 OptimUM-02 trial confirmed the treatment met its primary endpoint by significantly improving progression-free survival. The company expects to begin the first pre-submission in May, with the full NDA filing projected for completion in the second half of 2026. The inclusion in the RTOR program is expected to accelerate the regulatory timeline and path to commercialization. This development is viewed as a major de-risking event for the company's clinical pipeline, with analysts focused on its breakthrough potential in oncology.