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.
Publications
National targeted skin cancer screening to be accelerated with $10.3 million investment
The Albanese Government is investing $10.3 million to tackle the most common cancer in our sunburnt country, skin cancer.
FDA Grants RMAT Designation to Novel TIL Therapy OBX-115 in Melanoma
This designation follows the fast track designation that was granted to OBX-115 for the same indication in July 2024.
FDA Grants Fast Track Designation to VMT01 for Unresectable/Metastatic MC1R+ Melanoma
The FDA has granted fast track designation to the development of the targeted alpha-particle therapy (212Pb) VMT01 for the diagnosis and treatment of patients with unresectable or metastatic melanoma, as well as those who have demonstrated melanocortin 1 receptor (MC1R) expression, Perspective Therapeutics announced in a news release.