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
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organization(s) | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| EMA (1) | TP53 somatic variants | Chronic Lymphocytic Leukemia | Venetoclax | |
| EMA (1) | TP53 deletion | Chronic Lymphocytic Leukemia | Venetoclax | |
| EMA (1) | 17p deletion | Chronic Lymphocytic Leukemia | Venetoclax |