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