Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized venetoclax as a monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.
This is written in the approval document as:
Venclyxto monotherapy is indicated for the treatment of CLL in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor.
Citation
AbbVie Deutschland GmbH Co. KG. Venclyxto (venetoclax) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/venclyxto-epar-product-information_en.pdf. Revised October 2022. Accessed March 25, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | TP53 somatic variants | Chronic Lymphocytic Leukemia | Venetoclax | |
| Sensitivity (+) | TP53 deletion | Chronic Lymphocytic Leukemia | Venetoclax | |
| Sensitivity (+) | 17p deletion | Chronic Lymphocytic Leukemia | Venetoclax |