NDA Submission initiated from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence RTOR Program
“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.
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