Breyanzi

lisocabtagene maraleucel

Approval

ApplicationBLA 125714

Approval dateFeb 5, 2021

Approval year2021

SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company

FDA-approved use

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:Adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; orRefractory disease to first-line chemoimmunotherapy or relapse after first-line…

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 Breyanzi:

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