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 absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and 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 absence of 17p deletion or TP53 mutation in adult patients who have failed chemoimmunotherapy and 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) | 17p deletion | Chronic Lymphocytic Leukemia | Venetoclax | |
| EMA (1) | Wild type TP53 | Chronic Lymphocytic Leukemia | Venetoclax |