Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that TP53 somatic variants status confers therapeutic sensitivity to Idelalisib, Rituximab in patients with Chronic Lymphocytic Leukemia.
The European Medicines Agency (EMA) has authorized idelalisib in combination with rituximab for the first-line treatment of adult patients with chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or a TP53 mutation who are not eligible for any other therapies.
This statement is based on a regulatory approval from the European Medicines Agency:
Zydelig is indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.