Regulatory approval

Published by the Food and Drug Administration. Approved

The U.S. Food and Drug Administration granted accelerated approval to dostarlimab for the treatment of adult patients with mismatch repair deficient (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 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 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).

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	Any solid tumor	Dostarlimab

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2022-04-28	Food and Drug Administration	Indication received traditional approval.