Regulatory approval

Published by the Food and Drug Administration. Approved

JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microstallite instability-high (MSI-H).

This is written in the approval document.

Citation

GlaxoSmithKline LLC. Jemperli (dostarlimab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761174s010lbl.pdf. Revised March 2024. Accessed October 30, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	dMMR	Endometrial Carcinoma	Carboplatin, Dostarlimab, Paclitaxel
FDA (2)	MSI-H	Endometrial Carcinoma	Carboplatin, Dostarlimab, Paclitaxel

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2023-07-31	Food and Drug Administration	Indication received traditional approval.