BMY · News · 20260806N
Regulatory Approval Milestones
BRISTOL MYERS SQUIBB CO · 2026-08-06 · Importance 41 · Surprise 60 · In source text
The U.S. Food and Drug Administration approved Replimune's Tudriqev in combination with Bristol Myers Squibb's Opdivo for a difficult-to-treat form of advanced melanoma. The decision was supported by a 24.2% tumor shrinkage or disappearance rate and a median response duration of 14.1 months. The approval expands an Opdivo-containing regimen into an additional melanoma treatment setting and positions it against Iovance Biotherapeutics' Amtagvi.
Key facts
- The U.S. FDA approved Replimune's drug Tudriqev in combination with Bristol Myers Squibb's Opdivo for a difficult-to-treat form of advanced melanoma. source
- The FDA decision for Tudriqev was based on data showing a 24.2% tumor shrinkage or disappearance rate and a median response duration of 14.1 months. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | The U.S. FDA approved Replimune's drug Tudriqev in combination with Bristol Myers Squibb's Opdivo for a difficult-to-treat form of… |