FDA approved the original biologics license application for JEMPERLI on August 17, 2021, sponsored by GLAXOSMITHKLINE LLC. FDA’s record shows no approved efficacy supplement on the application since.
- Application
- BLA761223
- Sponsor
- GLAXOSMITHKLINE LLC
- Original approval
- Review
- priority review
- Submission class
- Type 9 - New indication submitted as distinct BLA, consolidated
- Active ingredient
- dostarlimab-gxly
Browse every approval whose brand starts with J, or the complete response letters FDA has published — the applications it did not approve.
Products under this application
| Ingredient and strength | Form | Route | Marketing status |
|---|---|---|---|
| dostarlimab-gxly 500MG/10ML | INJECTABLE | INJECTION | Prescription |
Approved efficacy supplements
An efficacy supplement is how a sponsor asks FDA to approve a change that needs clinical evidence — most often a new indication. FDA’s record gives each one a submission number, a date and a review priority. It does not say what any supplement approved, so neither does this page. The approval letter and label for each are on accessdata.fda.gov under the application number.
FDA’s record shows no approved efficacy supplement on this application.
Source: FDA’s Drugs@FDA application file, via openFDA (export 2026-09-03). Every field on this page comes from that record.
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