Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that TP53 somatic variants status confers therapeutic sensitivity to Acalabrutinib in patients with Chronic Lymphocytic Leukemia.
This statement is based on a regulatory approval from the Health Service Executive:
As monotherapy for the treatment of previously untreated CLL in the presence of 17p deletion or TP53 mutation in adult patients unsuitable for chemoimmunotherapy.