FDA Backs Darovasertib Phase 3 Trial Design in Uveal Melanoma
Source: Targeted Oncology, April 2025
Following a successful Type D meeting with the FDA, IDEAYA Biosciences announced a phase 3 registrational trial design to evaluate the safety and efficacy of darovasertib as neoadjuvant therapy for the treatment of patients with primary uveal melanoma.
The planned phase 3 randomized trial aims to assess the safety and efficacy of neoadjuvant darovasertib in patients with primary uveal melanoma. The trial will enroll approximately 520 patients and will utilize a 2:1 randomization to the darovasertib treatment arm vs the control arm.
Initiation of the phase study is planned for the first half of 2025.