Jemperli (dostarlimab) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

GlaxoSmithKline LLC. Jemperli (dostarlimab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761174s002lbl.pdf. Revised April 2022. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

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 solid tumors, as determined by an FDA-approved test, that have progressed on or following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	dMMR	Any solid tumor	Dostarlimab