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 previously untreated advanced follicular lymphoma. 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 previously untreated advanced follicular lymphoma.