Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that CCND1 status confers therapeutic sensitivity to Ibrutinib in patients with Mantle Cell Lymphoma.
The Republic of Ireland's Health Service Executive (HSE) has approved ibrutinib for reimbursement as a single agent treatment option for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. The treatment regimen further describes the eligibility criteria as requiring cyclin D1 overexpression or translocation breakpoints at t(11;14).
This statement is based on a regulatory approval from the Health Service Executive:
As a single agent for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).