Experts see Replimune’s Tudriqev approval as a step toward broader use of localized cancer therapies

Replimune received FDA approval last month for Tudriqev, an oncolytic virus injected directly into melanoma tumors, marking only the second such approval for a therapy delivered straight into a tumor.

The decision underscores growing interest in localized cancer treatments, which target the tumor site and may be especially valuable in early‑stage disease. Historical precedents include BCG for bladder cancer and Amgen’s Imlygic, the first FDA‑approved oncolytic virus in 2015.

While Imlygic’s sales have been modest, analysts at BMO Capital Markets estimate Tudriqev could generate roughly $1.3 billion in annual revenue by 2035 if market expectations are realized.

Experts note that broader adoption will require clear clinical benefits and solutions to manufacturing and delivery challenges.