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IDEAYA Biosciences to Initiate New Drug Application Submission from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence Real-time Oncology Review (RTOR) Program
IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, today announced that the U.S. Food and Drug Administration (FDA) has agreed to review its New Drug Application (NDA) for darovasertib in combination with crizotinib (darovasertib combination) for patients with first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM) under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program.
About this update from Ideaya Biosciences, Inc.
[{"type":"list","items":[{"val":[{"type":"text","content":"Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint and will be presented in a late-breaking oral presentation at ASCO 2026","length":168,"tagName":"p"}]},{"val":[{"type":"text","content":"IDEAYA to initiate the RTOR submission process with the first pre-submission in May, with completion of the NDA filing expected in H2 '26","length":141,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":309,"olType":false},{"type":"text","content":"SOUTH SAN FRANCISCO, Calif., April 30, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, today announced that the U.S. Food and Drug Administration (FDA) has agreed to review its New Drug Application (NDA) for darovasertib in combination with crizotinib (darovasertib combination) for patients with first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM) under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program.","length":501,"tagName":"p"},{"type":"image","alt":"(PRNewsfoto/IDEAYA Biosciences, Inc.)","displaySize":"","headline":null,"caption":"(PRNewsfoto/IDEAYA Biosciences, Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":261,"url":"https://media.zenfs.com/en/prnewswire.com/b53b2c167935532309987db78b249c89"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/9TYoum0K3OycBPFggMPOXw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ2MA--/https://media.zenfs.com/en/prnewswire.com/b53b2c167935532309987db78b249c89","width":400,"height":261}},"href":"https://mma.prnewswire.com/media/820568/IDEAYA_v2_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":""We are grateful for the continued partnership with the FDA and being accepted in the Oncology Center of Excellence Real-Time Oncology Review program based on the topline results from the OptimUM-02 trial. This is an important achievement for IDEAYA and the people living with mUM who today have very few treatment options. We believe the topline results from OptimUM-02 provide further evidence to support the potential benefit of the darovasertib combination in patients with first-line HLA*A2-negative mUM, and we look forward to working closely with the FDA through the RTOR process to make this promising new potential treatment...