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.
Regulatory
FDA Receives BLA for RP1 and Nivolumab Combo in Advanced Melanoma
The FDA has received a BLA submission seeking the accelerated approval of RP1 plus nivolumab for the potential treatment of adult patients with advanced melanoma who have received prior treatment with a regimen that contains a PD-1 inhibitor.
NICE Recommends Tebentafusp Reimbursement for HLA-A*02:01+ Uveal Melanoma
NICE has recommended the reimbursement for tebentafusp in HLA-A*02:01–positive unresectable or metastatic uveal melanoma.
Accelerated Approval Sought for RP1 Plus Nivolumab in Advanced Melanoma
A biologics license application was submitted to the FDA seeking the accelerated approval of RP1 (vusolimogene oderparepvec) plus nivolumab (Opdivo) for the treatment of adult patients with advanced melanoma who have received prior treatment with a regimen containing a PD1 inhibitor. The combination also received breakthrough therapy designation from the FDA for the same designation.