Darovasertib

Ideaya Biosciences reports positive Phase 2 data for darovasertib in neoadjuvant uveal melanoma, with 49% tumor shrinkage and 61% eye preservation. FDA supports eye preservation and time to vision loss as primary endpoints, potentially setting a new standard of care.

IDEAYA Biosciences announced interim clinical data for darovasertib in neoadjuvant uveal melanoma, showing 59% of patients with ≥20% ocular tumor shrinkage and 61% eye preservation rate. The FDA supports a potential Phase 3 trial, with eye preservation as the primary endpoint for enucleation patients and time to vision loss for plaque brachytherapy patients.

IDEAYA Biosciences reports positive Phase 2 data for darovasertib in neoadjuvant uveal melanoma, showing ~49% tumor shrinkage and ~61% eye preservation rate. The company plans to initiate a Phase 3 registrational trial following FDA guidance, targeting ~400 patients with primary endpoints of eye preservation and time to vision loss.

IDEAYA Biosciences to report interim Phase 2 data for darovasertib and provide a regulatory update from FDA Type C meeting in neoadjuvant uveal melanoma (UM) on September 23, 2024, at 8:00 a.m. ET.

Douglas B. Snyder joins IDEAYA Biosciences as SVP, General Counsel, bringing over 25 years of legal experience from GW Pharmaceuticals, Actelion Pharmaceuticals, Eisai, GSK, and the U.S. FDA.