FDA reverses course with accelerated nod for Tudriqev in melanoma

The US Food and Drug Administration (FDA) has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), an oncolytic immunotherapy from Woburn, Massachusetts-based biotech Replimune (Nasdaq: REPL), closing out a regulatory saga that had twice ended in rejection.

The therapy, previously known as RP1, is cleared for use alongside Bristol Myers Squibb's (NYSE: BMY) Opdivo (nivolumab) in adults with unresectable advanced cutaneous melanoma whose disease has progressed on an anti-PD-1 antibody-based regimen. It is injected directly into tumors, with imaging used to guide dosing of deeper and visceral lesions.