Regulatory approval

Published by the Food and Drug Administration. Approved

IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).

This is written in the approval document.

Citation

AstraZeneca UK Limited. Imfinzi (durvalumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761069s043lbledt.pdf. Revised August 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	Endometrial Carcinoma	Carboplatin, Durvalumab, Paclitaxel

Contributions

Date	Contributor	Description
2025-01-10	Van Allen lab	Additional FDA approvals for initial version
2024-06-14	Food and Drug Administration	Indication received traditional approval.