Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that MSI-H status confers therapeutic sensitivity to Carboplatin, Dostarlimab, Paclitaxel in patients with Endometrial Carcinoma.

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 statement is based on a regulatory approval from the Food and Drug Administration:

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. GlaxoSmithKline LLC. Jemperli (dostarlimab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761174s006lbl.pdf. Revised July 2023. Accessed October 6, 2026.

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.