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 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 is written in the approval document as:
Obinutuzumab in combination with bendamustine is indicated for the treatment of patients with previously untreated advanced follicular lymphoma.
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 |
| 2019-05-01 | Health Service Executive | Indication approved for reimbursement. |