BIOBRIEF
Replimune's RP1 (Tudriqev), an engineered tumor killing virus paired with Opdivo, won the non binding vote after two prior FDA rejections. The agency decides by Aug. 2, 2026.
An FDA advisory panel on Wednesday backed Replimune's RP1, a virus engineered to kill tumor cells and paired with Bristol Myers Squibb's Opdivo, for advanced melanoma that has stopped responding to standard immunotherapy, voting 10-3 that the combination worked in patients who had run out of other options (FierceBiotech).
The vote is a non-binding recommendation. The FDA has until Aug. 2, 2026, to make its own call on RP1, also known as vusolimogene oderparepvec and branded Tudriqev, and is not obligated to follow its outside advisers.
It is the drug's third attempt at approval. The agency issued a complete response letter in July 2025, calling Replimune's phase 1/2 trial neither adequate nor well-controlled, then rejected a resubmission in April 2026 as "insufficient." After the second refusal, Replimune's chief executive called the decision "deeply disappointing" and the company cut roughly 60% of its workforce. The third submission re-anchored on the same Ignyte study, this time with added overall-survival data from 140 patients.
On the yes side, Hussein Tawbi of MD Anderson told the panel the tumors that shrank translated into clinical benefit for patients with no other options, per FierceBiotech. On the no side, Mayo Clinic biostatistician Karla Ballman said the methodological concerns the FDA had flagged left her with too much uncertainty. Panelists also pointed to an ongoing phase 3 trial, Ignyte-3, as the read-out that will decide the drug's fate.