For a third time, Replimune will submit its experimental cancer therapy for approval, following what the Massachusetts-based biotechnology company described as “productive” talks with the Food and Drug Administration.
According to a Friday announcement from Replimune, the two parties are aligned on a path forward for the therapy, which is codenamed RP1 and has been tested in combination with Bristol Myers Squibb’s Opdivo as a treatment for skin cancer. Replimune plans to file another marketing application “in the coming days,” and claims the FDA views this case as an urgent matter and intends to prioritize its review.
"We are grateful to the FDA leadership for their willingness to engage in a collaborative dialogue towards finding a meaningful path forward for RP1," said Replimune CEO Sushil Patel in a statement.
Replimune’s update is the latest curve in a what’s become a winding, highly unusual journey to approval. The company first submitted RP1 to the FDA in late 2024, based on data from a mid-stage clinical trial titled “IGNYTE.” The experiment enrolled 140 people with advanced melanoma, whose disease continued to progress even after receiving a kind of cancer-fighting, immune system-triggering drug known as a “PD-1 inhibitor.” Results showed that RP1 plus Opdivo — which is itself a PD-1 blocker — shrank tumors in a third of the participants. And in 15%, treatment wiped out all visible traces of the cancer.
