Updated interim phase 2 data showed the clinical efficacy and safety of neoadjuvant darovasertib monotherapy in localized uveal melanoma.
Regulatory
FDA Grants Breakthrough Therapy to IDE196 in Primary Uveal Melanoma
The FDA granted Breakthrough Therapy designation to IDE196 for the neoadjuvant treatment of primary uveal melanoma when enucleation has been recommended.
FDA Backs Darovasertib Phase 3 Trial Design in Uveal Melanoma
Following a successful Type D meeting with the FDA, IDEAYA Biosciences announced a phase 3 registrational trial design to evaluate the safety and efficacy of darovasertib as neoadjuvant therapy for the treatment of patients with primary uveal melanoma.
5 Novel FDA Approvals Notched in 2024
Among the 55 novel drugs that crossed the regulatory finish line last year were notable new mechanisms of action, coming particularly in the oncology and neurosciences spaces.