Regulatory approval

Published by the European Medicines Agency.

The European Medicines Agency (EMA) has authorized durvalumab in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with durvalumab as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) or durvalumab in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).

This is written in the approval document as:

IMFINZI in combination with carboplatin and paclitaxel is indicated for the first-line treatment of adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy, followed by maintenance treatment with IMFINZI as monotherapy in endometrial cancer that is mismatch repair deficient (dMMR) or IMFINZI in combination with olaparib in endometrial cancer that is mismatch repair proficient (pMMR).

Citation

AstraZeneca AB. Imfinzi (durvalumab) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf. Revised August 2024. Accessed August 24, 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	Carboplatin, Durvalumab, Paclitaxel
Sensitivity (+)	pMMR	Endometrial Carcinoma	Carboplatin, Durvalumab, Olaparib, Paclitaxel