The FDA has issued a CRL to Replimmune regarding the BLA for vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.

Melanoma testing could one day be done at home with a skin patch and test strip with two lines, similar to COVID-19 home tests, according to University of Michigan researchers.

III/IV resectable melanoma remained event-free at four years from the start of neoadjuvant systemic treatment.

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.