FDA's Path Forward for RP1: Acceptance of BLA Resubmission Marks a Milestone in Advanced Melanoma Treatment

The FDA has accepted the RP1 BLA resubmission, initiating a formal review of RP1 (vusolimogene oderparepvec) in combination with nivolumab for PD‑1–resistant advanced melanoma. This shifts the program from regulatory limbo into an active, time‑bound review with immediate implications for institutional planning and stakeholder timelines.

Acceptance follows a resubmission that addressed earlier agency questions and provided additional analyses the FDA judged sufficient to resolve items cited in the prior Complete Response Letter. The filing has therefore moved from a stalled dossier to an evaluable submission, allowing the agency to proceed with substantive review rather than leaving critical issues open.

Acceptance also establishes a PDUFA date and starts the FDA review clock, framing an expected regulatory milestone window that helps teams set downstream timelines and expectations.

Clinical programs can begin operational planning now to prepare for potential RP1 availability: update formularies; educate tumor boards on RP1’s intended indication in PD‑1–resistant advanced melanoma; and establish logistics for intratumoral administration alongside nivolumab. Teams should schedule pharmacist and nursing training for administration and monitoring, map infusion and procedure workflows, and assess supply‑chain and storage needs so operational barriers do not delay access if approval follows. Early payer engagement and coding‑workflow preparation can shorten time‑to‑treatment after regulatory clearance.

Overall, FDA acceptance narrows near‑term uncertainty and enables health systems to align clinical pathways so eligible patients can access RP1 promptly if the agency ultimately approves it.

Key Takeaways:

• Acceptance converts RP1 from unresolved status into an active FDA review with an assigned review clock for potential market authorization.
• Oncology programs and patients with PD‑1–resistant advanced melanoma can prepare—update formularies, train teams for intratumoral and combination administration, and plan payer engagement—to reduce time‑to‑treatment if approval follows.
• The PDUFA‑driven timeline sets an expected window for the FDA’s decision; final approval remains contingent on the agency’s benefit–risk assessment and may require further action.