Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to dostarlimab in combination with carboplatin and paclitaxel, followed by dostarlimab 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 as:

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).

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.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	dMMR	Endometrial Carcinoma	Carboplatin, Dostarlimab, Paclitaxel
Sensitivity (+)	MSI-H	Endometrial Carcinoma	Carboplatin, Dostarlimab, Paclitaxel