Recovery for Replimune: Accelerated Approval for Cancer Drug Twice Spurned by FDA

Frank Vinluan / medcitynews - Replimune went from an FDA rejection to a resubmission, a positive advisory committee vote, and finally an accelerated regulatory approval for advanced melanoma — all in less than four months. The FDA nod for Replimune’s oncolytic viral therapy, Tudriqev,…

AI Summary: After two previous turns in the penalty box, the FDA granted accelerated approval to Replimune’s oncolytic immunotherapy Tudriqev (RP1) in combination with nivolumab for advanced melanoma. The decision follows a favorable advisory committee outcome and positions a once-spurned viral-based therapy back into the clinic as a new option for patients with limited choices.

#pharmaceuticals #biotech #drugdevelopment #fda #oncology #cancerresearch #clinicaltrials

Clinical community reaction and rollout: experts and training (4)
Regulatory comeback: FDA approves Tudriqev after two rejections (4)
Replimune announcements and company leadership reactions (3)
All Other Stories

Clinical community reaction and rollout: experts and training

Dani Castillo: Hands-On Tudriqev Training Follows FDA Approval in Melanoma

17 days / oncodaily

Kevin Harrington: FDA Approval Marks a Major Breakthrough for RP1

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Victor Moreno։ FDA Approves RP1 Plus Nivolumab for PD-1-Refractory Melanoma

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Recovery for Replimune: Accelerated Approval for Cancer Drug Twice Spurned by FDA

22 days / medcitynews / Frank Vinluan

Regulatory comeback: FDA approves Tudriqev after two rejections

FDA reverses course, approves melanoma therapy after 2 rejections

19 days / beckershospitalreview / Ella Jeffries

Third Time’s the Charm: FDA Approves Replimune’s Tudriqev (RP1) for Advanced Melanoma

22 days / oncodaily

FDA Grants Accelerated Approval to Tudriqev Plus Nivolumab for Advanced Melanoma

22 days / oncodaily

FDA panel backs melanoma therapy after 2 rejections

26 days / beckershospitalreview / Ella Jeffries

Replimune announcements and company leadership reactions

Jeannie Hou: Big Step for Melanoma Patients

22 days / oncodaily

Replimune Announces FDA Approval of Oncolytic Immunotherapy

23 days / oncodaily

Replimune Announces Favorable Outcome of FDA’s Advisory Committee Meeting

28 days / oncodaily

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Nosakhare Paul Ilerhunmwuwa Receives 2026 Resident/Fellow Award for Advanced Melanoma Research – MRF

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New melanoma drug based on herpes virus granted FDA accelerated approval

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Blog Post

The FDA has granted accelerated approval to Replimune’s oncolytic immunotherapy TUDRIQEV (vusolimogene oderparepvec, RP1) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma whose disease has progressed following treatment. The decision, announced Aug. 6, 2026, follows two prior FDA rejections and a favorable Cellular, Tissue, and Gene Therapies Advisory Committee vote (10–3 on July 30) that the trial results were evaluable and clinically meaningful. Replimune has thanked patients, families and clinicians who participated in its trials, and the approval returns a once-spurned viral-based therapy to the clinic as an additional option for patients — positioned by some observers as a more convenient alternative to an existing cell therapy in this setting.

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