Tecelra

afamitresgene autoleucel

Approval

ApplicationBLA 125789

Approval dateAug 1, 2024

Approval year2024

SponsorAdaptimmune LLC

FDA-approved use

Treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared Companion Diagnostic devices

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 Tecelra:

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