IDEAYA Biosciences, Inc. (IDYA) is moving ahead with a New Drug Application for its Darovasertib- Crizotinib combination after the therapy met the primary endpoint in the Phase 2/3 OptimUM-02 trial for first-line HLA*A2-negative metastatic uveal melanoma (mUM).
The FDA has agreed to review the application under its Real-Time Oncology Review (RTOR) program, allowing components of the NDA to be submitted and reviewed on a rolling basis.
Metastatic uveal melanoma (mUM) is a rare and aggressive eye cancer with limited treatment options, particularly for patients who are HLA*A2-negative. IDEAYA said the OptimUM-02 trial showed a 58% reduction in risk of disease progression versus investigator's choice therapy, with median progression-free survival of 6.9 months vs. 3.1 months. The combination also achieved a 37.1% response rate, including five complete responses, compared with 5.8% in the control arm.
The company plans to submit the first RTOR pre-submission in May, with full NDA completion expected in the second half of 2026. Safety findings were consistent with previously reported data for each drug.
IDYA has traded between $16.82 and $39.28 over the past year. The stock closed Wednesday's trading at $28.05, down 3.51%. In pre-market trading, the stock is at $28.50. up 1.60%.
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