Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized idelalisib in combination with rituximab for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or a TP53 mutation who are not eligible for any other therapies.

This is written in the approval document as:

Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.

Citation

Gilead Sciences Ireland UC. Zydelig (idelalisib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/zydelig-epar-product-information_en.pdf. Revised June 2023. Accessed March 26, 2024.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	TP53 deletion	Chronic Lymphocytic Leukemia	Idelalisib, Rituximab
EMA (1)	TP53 Somatic variants	Chronic Lymphocytic Leukemia	Idelalisib, Rituximab
EMA (1)	17p deletion	Chronic Lymphocytic Leukemia	Idelalisib, Rituximab

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2014-09-18	European Medicines Agency	Indication received approval from the European Commission.