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.
The Republic of Ireland's Health Service Executive (HSE) has approved acalabrutinib (tablets) for reimbursement as a monotherapy treatment option for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or TP53 mutation who are unsuitable for chemoimmunotherapy.
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.