Regulatory approval
Published by the European Medicines Agency.
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.| 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 |