A potentially registrational trial of trial for darovasertib in neoadjuvant UM setting
Latest Information Update: 17 Apr 2025
At a glance
- Drugs Darovasertib (Primary)
- Indications Uveal melanoma
- Focus Registrational; Therapeutic Use
Most Recent Events
- 14 Apr 2025 According to an IDEAYA Biosciences media release, Company announced a successful FDA Type D meeting on the Phase 3 registrational trial design that will assess the safety and efficacy of darovasertib for potential regulatory approval as neoadjuvant therapy for primary uveal melanoma (UM).
- 31 Mar 2025 According to an IDEAYA Biosciences media release, study would evaluate neoadjuvant darovasertib in primary UM patients who are eligible for enucleation (Cohort 1) or plaque brachytherapy (Cohort 2).
- 04 Nov 2024 According to an IDEAYA Biosciences media release, Following a successful Type C meeting with the U.S. Food and Drug Administration (FDA), IDEAYA is finalizing the Phase 3 registrational trial protocol and is targeting to initiate its potential registration-enabling trial in the first half of 2025.