Amtagvi

lifileucel

Approval

ApplicationBLA 125773

Approval dateFeb 16, 2024

Approval year2024

SponsorIovance Biotherapeutics, Inc

FDA-approved use

Treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s)

Approval package

Query with Claude

The fda-analyst skill answers natural-language questions about this approval by fetching the relevant FDA review PDFs at query time.

git clone https://github.com/cbetz/trove
cp -r trove/skills/fda-analyst ~/.claude/skills/

Example prompts for Amtagvi:

"What was the basis for Amtagvi's approval — what trials, what endpoints?"
"What adverse events did the FDA flag in the Amtagvi medical review?"
"What regulatory pathway did Amtagvi use — priority review, breakthrough, accelerated approval?"