IDEAYA Biosciences, Inc. announced on April 14, 2025, a successful FDA Type D meeting regarding the Phase 3 registrational trial design for darovasertib. This trial will assess the safety and efficacy of darovasertib as neoadjuvant therapy for primary uveal melanoma (UM) for potential regulatory approval.
The successful meeting provides a clear registrational path for darovasertib, utilizing primary clinical endpoints of eye preservation and proportion of patients with vision loss. The trial design incorporates FDA guidance and feedback, with no detriment to event-free survival (EFS) required as a secondary endpoint for both cohorts.
IDEAYA is targeting to initiate the Phase 3 randomized clinical trial in the first half of 2025, projecting to enroll approximately 520 patients across two cohorts: enucleation eligible UM patients and plaque brachytherapy eligible UM patients. This advancement follows darovasertib's recent U.S. FDA Breakthrough Therapy Designation in neoadjuvant UM.
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