Drugs & FDA The FDA's Reviewers Called This Melanoma Data 'Not Interpretable.' Nine Days Later, the Agency Approved the Drug.
Twice the FDA rejected Replimune's engineered-herpes melanoma therapy, its reviewers calling the single-arm trial not interpretable. The design never changed. A 10-3 advisory vote came anyway, and nine days after that memo, the accelerated approval.
By Lena Marshall · August 16, 2026