IDEAYA Biosciences, Inc. announced on March 31, 2025, that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) for darovasertib. This designation is for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM) for whom enucleation has been recommended.
The BTD application was supported by updated interim clinical data from an ongoing Phase 2 open-label trial, NCT05907954, evaluating darovasertib monotherapy in the neoadjuvant setting. Interim data presented in September 2024 demonstrated an 82% ocular tumor shrinkage rate and a 61% eye preservation rate in UM patients.
This designation is expected to expedite the development and regulatory review of darovasertib, facilitating more intensive FDA guidance and eligibility for rolling submission and priority review. IDEAYA plans to initiate a Phase 3 randomized registrational trial in neoadjuvant UM in the first half of 2025, addressing a projected annual incidence of approximately 12,000 patients in North America, Europe, and Australia.
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