Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to dostarlimab for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

This is written in the approval document as:

JEMPERLI is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of adult patients with dMMR recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following prior treatment with a platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

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	Dostarlimab