IDEAYA Biosciences Inc. (NASDAQ: IDYA) announced the U.S. Food and Drug Administration agreed to review its New Drug Application for darovasertib in combination with crizotinib under the Oncology Center of Excellence Real-Time Oncology Review program.

The combination targets patients with first-line HLA*A2-negative metastatic uveal melanoma. IDEAYA plans to begin the RTOR submission process in May, with completion of the NDA filing expected in the second half of 2026.

The Phase 2/3 OptimUM-02 trial met its primary endpoint on April 13. The combination reduced the risk of disease progression by 58% with a hazard ratio of 0.42 and achieved a median progression-free survival of 6.9 months versus 3.1 months in the investigator choice of therapy arm, according to blinded independent central review.

The overall response rate reached 37.1%, including 5 complete responses, compared to 5.8% in the control arm. The median duration of response was 6.8 months. Overall survival data were not yet mature, though the combination showed an early trend in overall survival improvement versus the control arm.

The FDA's OCE RTOR program allows applicants to pre-submit NDA components for review before complete filing submission. The program aims to provide a more efficient review process for treatments.

"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," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences.

Full results from the OptimUM-02 trial will be presented at the 2026 American Society of Clinical Oncology annual meeting in Chicago. IDEAYA is conducting additional clinical trials of darovasertib in HLA*A2-positive metastatic uveal melanoma and in neoadjuvant and adjuvant settings of primary uveal melanoma.