The FDA granted Breakthrough Therapy designation to IDE196 for the neoadjuvant treatment of primary uveal melanoma when enucleation has been recommended.
Regulatory
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.
FDA Grants Priority Review to RP1 Plus Nivolumab for Advanced Melanoma After Anti–PD-1 Therapy
The FDA has accepted and granted priority review to the biologics license application (BLA) seeking the approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab (Opdivo) for the treatment of adult patients with advanced melanoma who have received prior treatment with a PD-1 inhibitor–containing regimen.