KG. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

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

Indication	Statements
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.	3
Venclyxto monotherapy is indicated for the treatment of CLL in the absence of 17p deletion or TP53 mutation in adult patients who have failed chemoimmunotherapy and a B-cell receptor pathway inhibitor.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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
Sensitivity (+)	17p deletion	Chronic Lymphocytic Leukemia	Venetoclax
Sensitivity (+)	Wild type TP53	Chronic Lymphocytic Leukemia	Venetoclax