Abecma

idecabtagene vicleucel

Approval

ApplicationBLA 125736

Approval dateMar 26, 2021

Approval year2021

SponsorCelgene Corporation, a Bristol-Myers Squibb Company

FDA-approved use

s:Treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody

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 Abecma:

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