Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that TP53 somatic variants status confers therapeutic sensitivity to Ibrutinib in patients with Chronic Lymphocytic Leukemia.
The Republic of Ireland's Health Service Executive (HSE) has approved ibrutinib for reimbursement as a monotherapy, first-line treatment option for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who are unsuitable for chemoimmunotherapy and whose tumors have 17p deletion or TP53 mutated disease.
This statement is based on a regulatory approval from the Health Service Executive:
As a single agent for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) in first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.