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An FDA advisory committee voted 10-3 that efficacy results from the IGNYTE study are evaluable and clinically meaningful for RP1 in combination with Opdivo in adults with advanced melanoma that has progressed after an anti-PD-1-containing regimen.

The vote by the Cellular, Tissue, and Gene Therapies Advisory Committee is not an approval.

RP1 is an oncolytic immunotherapy based on a modified herpes simplex virus.

It is injected directly into a tumor and is designed to prompt an immune response against tumors elsewhere in the body.

The application has gone through three review cycles and two complete response letters, issued in July 2025 and April 2026.

In IGNYTE, the objective response rate was 33.6%, with a median duration of response of 24.8 months and median overall survival of 32.9 months.

Treatment-related side effects of grade 3 or higher occurred in 31.4% of participants.

Committee members who voted no cited standards of evidence rather than the drug’s potential value.

Amtagvi, a tumor-infiltrating lymphocyte therapy, is the only FDA-approved treatment for melanoma that has progressed after anti-PD-1 therapy.

Replimune’s briefing materials cited Amtagvi‘s 2024 accelerated approval, which was also based on a single-arm trial and showed a response rate, as precedent for approving RP1 on similar evidence.

A patient’s account of TIL therapy reveals the process involves surgery to collect immune cells from a tumor, several weeks while those cells are grown in a lab, chemotherapy to prepare the body, the cell infusion, and then therapy like interleukin-2, or IL-2.

For patients like Michael Goldman, who has stage 4 melanoma and received TIL therapy, the experience was challenging but ultimately successful.

Goldman described the IL-2 phase as the most difficult part, with chills beginning about 30 minutes after each dose.

He said, “Once I got that first chill, I knew it was coming,” and the rigors built into 20 to 30 minutes of shaking and fever before subsiding.

Despite the challenges, Goldman considers TIL therapy a success, saying, “Eleven days of your life to sacrifice in the hospital, for leaving the hospital and not having to take anything and have your body actively fighting successfully against your cancer, is a win.”

His advice to patients who are newly diagnosed centers on time, saying, “Every day you can prolong your life is an extra day of a chance that something else comes out that can save your life.”

The FDA is expected to act by Aug. 2.

For those affected by this development, the need for safe and effective treatment options remains.