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# Breakthrough Status for Uveal Melanoma Therapy
- URL: https://www.fdaweb.com/breakthrough-status-for-uveal-melanoma-therapy/
- Published: 2025-04-04T12:00:00.000Z
- Updated: 2026-09-14T14:57:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158959

FDA has granted Ideaya Biosciences a breakthrough therapy designation for darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor for neoadjuvant use in adult patients with primary uveal melanoma (UM) for whom enucleation has been recommended.

The designation was based on interim clinical data from an ongoing Phase 2 open-label trial (NCT05907954) evaluating darovasertib monotherapy in the neoadjuvant setting for localized UM. The therapy demonstrated an 82% ocular tumor shrinkage rate and a 61% eye preservation rate in UM patients, according to the company. Ideaya is planning a Phase 3 registrational study to evaluate darovasertib in primary UM patients who are eligible for enucleation (Cohort 1) or plaque brachytherapy (Cohort 2), it says.