FDA Grants Breakthrough Therapy to IDE196 in Primary Uveal Melanoma
Source: Cure Today, April 2025
The FDA granted Breakthrough Therapy designation to IDE196 for the neoadjuvant treatment of primary uveal melanoma when enucleation has been recommended.
Treatment with IDE196 (darovasertib) has been granted Breakthrough Therapy designation by the United States Food and Drug Administration (FDA) for the neoadjuvant treatment of adult patients with primary uveal melanoma for whom enucleation has been recommended, according to a news release from IDEAYA Biosciences, Inc.
The Breakthrough Therapy designation from the FDA follows a Fast Track designation granted by the regulatory agency for the potential first-in-class protein kinase C (PKC) inhibitor, IDE196, in combination with Xalkori (crizotinib) for adult patients being treated for metastatic uveal melanoma, in which, a phase 2/3 registration-enabling trial of the IDE196 and Xalkori combination in 1L HLA-A2-negative metastatic uveal melanoma is ongoing.