Zydelig (idelalisib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

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

Indication	Statements
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.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	TP53 deletion	Chronic Lymphocytic Leukemia	Idelalisib, Rituximab
Sensitivity (+)	TP53 somatic variants	Chronic Lymphocytic Leukemia	Idelalisib, Rituximab
Sensitivity (+)	17p deletion	Chronic Lymphocytic Leukemia	Idelalisib, Rituximab