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# Ideaya Bio Plans Phase 3 for Darovasertib
- URL: https://www.fdaweb.com/ideaya-bio-plans-phase-3-for-darovasertib/
- Published: 2024-09-23T12:00:00.000Z
- Updated: 2026-09-14T14:42:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157837

Ideaya Biosciences says it is advancing darovasertib, an investigational therapy for neoadjuvant uveal melanoma (UM), into a Phase 3 trial following “positive interim” Phase 2 clinical trial data and a successful FDA Type C meeting on the registrational trial design for seeking regulatory approval.

“Darovasertib has demonstrated compelling preliminary clinical efficacy and a favorable \[adverse event\] AE profile in the neoadjuvant UM setting, with approximately 49% of patients demonstrating greater than 30% tumor shrinkage and importantly approximately 61% eye preservation rate for enucleation patients,” the company says. “The successful FDA Type C meeting provides darovasertib a potential registrational path in neoadjuvant UM, using primary clinical endpoints of eye preservation and time to vision loss, with no detriment to EFS \[event-free-survival\] in the treatment arms as a secondary endpoint.” Additionally, discussions are ongoing with FDA to include objective response rate as a potential surrogate and composite endpoint to support earlier approval pathways, it says.

Darovasertib is described as a potent and selective protein kinase C (PKC) inhibitor that is being evaluated in four ongoing clinical trials, including two under a collaboration with Pfizer.