Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that Wild type TP53 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 absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and 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 absence of 17p deletion or TP53 mutation in adult patients who have failed chemoimmunotherapy and a B-cell receptor pathway inhibitor.