FDA Grants Breakthrough Therapy Designation to Darovasertib in Melanoma
Source: Targeted Oncology, March 2025
A phase 3 trial plans to further assess neoadjuvant darovasertib for the potential treatment of patients with primary uveal melanoma.
- The FDA has granted breakthrough therapy designation (BTD) to darovasertib as a neoadjuvant treatment for adult patients with primary uveal melanoma.
- Darovasertib is a potential first-in-class protein kinase C (PKC) inhibitor.
- Updated findings from a phase 2 trial (NCT05907954) evaluating neoadjuvant darovasertib for patients with uveal melanoma support this BTD.
The FDA has granted darovasertib, a potential first-in-class PKC inhibitor, BTD for the potential treatment of adult patients with primary uveal melanoma for whom enucleation has been recommended.