Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that TP53 somatic variants status confers therapeutic sensitivity to Idelalisib, Ofatumumab in patients with Chronic Lymphocytic Leukemia.
The Republic of Ireland's Health Service Executive (HSE) has approved idelalisib in combination with ofatumumab for reimbursement as a treatment option for the first line treatment of adult patients with chronic lymphocytic leukemia (CLL) in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies.
This statement is based on a regulatory approval from the Health Service Executive:
In combination with Ofatumumab 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.