Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that 17p deletion status confers therapeutic sensitivity to Venetoclax in patients with Chronic Lymphocytic Leukemia.
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 statement is based on a regulatory approval from the European Medicines Agency:
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.