Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved rituximab (375 mg/m^2) in combination with chemotherapy (21 day) for reimbursement as a treatment option for the induction treatment of previously untreated or relapsed / refractory CD20 positive patients with follicular lymphoma. The European Medicine Agency's product information for rituximab includes an indication for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy, and the product information cites four clinical trials that showed significant improvements in response rates in treating this indication with chemotherapy in combination with rituximab versus just chemotherapy alone. The four clinical trials and chemotherapy regimens evaluated are: M39021 with CVP, GLSG'00 and CHOP, OSHO-39 and MCP, and FL2000 and CHVP-IFN.

This is written in the approval document as:

In combination with chemotherapy for induction treatment of previously untreated or relapsed/ refractory CD 20 positive patients with follicular lymphoma.

Reimbursement

Hospital

Citation

riTUXimab 375 mg/m2 Combination Therapy-21 day, 2025, version number 2a, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6642/542_v2a_riTUXimab_375_mgm2_CombinationTherapy.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Contributions