FDA Grants Accelerated Approval to Replimune's Oncolytic Viral Therapy Tudriqev for Anti-PD-1 Refractory Melanoma

Two complete response letters preceded the approval

The FDA issued complete response letters on the RP1 application in July 2025 and on April 10, 2026. Sushil Patel, Replimune's chief executive, said then that it was "deeply disappointing that the FDA has not exercised regulatory flexibility to meet patients' needs given the data supporting strong efficacy and the favorable safety profile," and told investors that without timely accelerated approval the development of RP1 would not be viable, and that the company would eliminate jobs and substantially scale back its U.S. manufacturing. Its April release said a different review team had been appointed for the resubmission and had declined to meet. On May 29 the company said it had aligned with the agency on a path forward and that the FDA would prioritize the resubmitted file, which went before the Cellular, Tissue, and Gene Therapies Advisory Committee on July 30, 2026.

What the 91 evaluable patients showed

IGNYTE enrolled 140 adults with stage IIIB, IIIC or IV unresectable melanoma who had progressed on at least eight consecutive weeks of prior anti-PD-1-based therapy. Ninety-one of them had at least one non-injected lesion and made up the efficacy-evaluable population, in which the objective response rate was 24.2% and the median duration of response 14.1 months. Eighty percent had stage 4 disease, 54% were PD-L1 negative, 45% had lung lesions, 24% had liver lesions and 13% had received anti-PD-1 in the adjuvant setting. In April, arguing against the second complete response letter, Replimune put the IGNYTE response rate at 34% with a median duration of 24.8 months. The label figures come from the 91-patient subset. Replimune says the IGNYTE results appeared in the Journal of Clinical Oncology. The figures above come from the FDA announcement and the company's own releases.

Into the tumor every two weeks

Tudriqev goes directly into tumors every two weeks for eight doses, with a lower concentration for the first dose and a higher one thereafter, and the volume set by tumor size. Injection covers superficial as well as deep and visceral lesions, the latter under imaging guidance. Nivolumab begins intravenously at week three, and antiviral use forces a 72-hour delay before a dose. Nothing in the indication calls for a biomarker or a companion diagnostic, and PD-L1 negative patients made up more than half the registrational cohort. Serious adverse reactions occurred in 35% of the 140 treated patients, and 2.9% discontinued Tudriqev permanently.

Advanced melanoma patients have few options after anti-PD-1 therapy and face high morbidity and poor survival outcomes. With the approval of TUDRIQEV, we have a potent oncolytic immunotherapy that can be used in a broad population, including BRAF-naïve or pretreated, and adjuvant relapsed patients.

That is Michael K. Wong, MD, PhD, IGNYTE primary investigator and former physician in chief at Roswell Park Comprehensive Cancer Center.

The commercial build behind a 60-day launch promise

Michelle DiNapoli became chief commercial officer on Aug. 18 after seven years at Deciphera Pharmaceuticals, where she built the U.S. sales force, and 16 years at Genentech across the breast, lung and colorectal franchises. Her inducement awards, disclosed Aug. 19, were options on 150,000 shares at $15.58 plus 100,000 restricted stock units. Replimune held $195.3 million in cash and short-term investments at June 30, down from $268.9 million at its March 31 fiscal year end, and took in $141.0 million net from an August stock sale. Patel told investors on Aug. 14 that product would be in the market within 60 days.

Why This Matters to the APO|APE Reader

IGNYTE-3 does not read out overall survival until 2030, and continued approval turns on it, so the label as written stands for roughly four years on response rate alone. Treating sites carry the near-term work of eight visits at two-week intervals, imaging support whenever a target lesion is visceral, and the contact precautions a live HSV-1 product requires, which the label extends to caregivers, close contacts and newborns. The confirmatory trial also enrolls a different population from the approved one, patients who have progressed on both anti-PD-1 and anti-CTLA-4 therapy or who cannot receive anti-CTLA-4.