Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	TP53 Somatic variants	Chronic Lymphocytic Leukemia	Venetoclax
EMA (1)	TP53 deletion	Chronic Lymphocytic Leukemia	Venetoclax
EMA (1)	not 17p deletion	Chronic Lymphocytic Leukemia	Venetoclax