Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that CD20 + status confers therapeutic sensitivity to Bendamustine, Obinutuzumab in patients with Follicular Lymphoma.
The Republic of Ireland's Health Service Executive (HSE) has approved obinutuzumab in combination with bendamustine for reimbursement as a treatment option for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. The treatment regimen describes eligibility criteria separately for use within the first and second line of treatment. In a first line setting, patients must have previously untreated, CD20-positive follicular lymphoma (grade 1 to 3a) with advanced disease (stage III, stage IV, or stage II with bulk disease [tumor >= 7 cm in the greatest dimension]), ECOG status 0-2, and adequate hematological, renal, and liver status. In the second line setting, patients must have CD20-positive indolent non-Hodgkin lymphoma refractory to rituximab, ECOG 0-2 (ECOG 3 at the discretion of the treating clinician), and adequate hematological, renal, and liver status.
This statement is based on a regulatory approval from the Health Service Executive:
Obinutuzumab in combination with bendamustine is indicated for the treatment of patients with follicular lymphoma (FL) who did not respond or who progressed during or up to 6 months after treatment with rituximab or a riTUXimab-containing regimen.