Carvykti

ciltacabtagene autoleucel

Approval

ApplicationBLA 125746

Approval dateFeb 28, 2022

Approval year2022

SponsorJanssen Biotech, Inc

FDA-approved use

s: Treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide

Approval package

↗ Drugs@FDA: full approval-package overview (every PDF the FDA released)
↗ FDA-approved label (PDF)

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 Carvykti:

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