Regulatory approval
Published by the Health Service Executive. Approved
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 is written in the approval document as:
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.
Reimbursement
ODMS
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | CD20 + | Follicular Lymphoma | Bendamustine, Obinutuzumab |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2026-08-02 | Van Allen lab | Initial curation of into moalmanac-db |
| 2017-11-01 | Health Service Executive | Indication approved for reimbursement. |