FDA’s briefing document for Thursday’s advisory committee meeting doesn’t hedge: the overall survival analysis from Replimune’s IGNYTE study is “not interpretable.” That’s the agency’s own reviewers talking, two days before the Cellular, Tissue, and Gene Therapies Advisory Committee votes on whether RP1’s data are even evaluable.
I’ve read both prior complete response letters on this drug. The first, in July 2025, said IGNYTE wasn’t “adequate and well-controlled.” The second, dated April 10, said FDA “would not recommend” seeking approval off a single-arm design at all, a position Replimune’s April 10 announcement confirms hasn’t budged. Same objection, three rounds running, as Replimune has laid out in its own public disclosures.
The old yardstick here was Amtagvi: a single-arm trial got Iovance to approval in previously-treated melanoma with no comparator arm. Keytruda, Opdivo and Yervoy cleared on similar designs. Replimune is betting FDA still measures by that stick. The briefing docs suggest the agency has quietly moved the bar on what counts as interpretable single-arm evidence, and RP1 is absorbing the cost of that shift.
Replimune’s counter, that randomizing anti-PD-1 failures to a comparator arm is unethical, is the kind of line reviewers write and then watch rejected anyway. The stock dropped more than 32%, to $5.78, on the briefing docs alone.
Thursday’s vote covers one question: are IGNYTE’s results evaluable and clinically meaningful. FDA’s own PDUFA deadline hits August 2. Worth watching whether the panel splits from the reviewers — that gap is the only thing standing between this drug and a third rejection.
Rebecca Lauren