On April 30, 2026 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, reported 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.
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"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 available to patients as quickly as possible," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.
On April 13th, IDEAYA reported positive topline data from the Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib in 1L HLA*A2-negative mUM. The trial met its primary endpoint, with the combination reducing the risk of disease progression by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001) and achieving a statistically significant improvement in median progression-free survival (PFS) of 6.9 months versus 3.1 months in the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR). On secondary endpoints, an overall response rate (ORR) of 37.1%, including 5 complete responses, was observed in patients treated with the darovasertib combination versus 5.8% in the ICT arm (p-value: <0.0001) with a median duration of response (DOR) of 6.8 months. Overall survival (OS) data were not yet mature, however the darovasertib combination did show an early trend in OS improvement versus the ICT arm. The combination was generally well-tolerated with a manageable safety profile consistent with previously reported results and known side-effects of each drug.
The FDA’s OCE RTOR program allows an applicant to pre-submit components of its NDA to allow the FDA to review clinical trial data before the complete filing is submitted and aims to provide a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. IDEAYA plans to initiate the RTOR submission process with the first pre-submission targeted for May, with completion of the NDA filing expected in the second half of 2026.
Full results from the OptimUM-02 trial will be presented in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place in Chicago, Illinois. IDEAYA is also conducting clinical trials of darovasertib in HLA*A2-positive mUM as well as in the neoadjuvant and adjuvant settings of primary uveal melanoma.
(Press release, Ideaya Biosciences, APR 30, 2026, View Source [SID1234664981])