Bendamustine in combination with rituximab can continue to be made available within NHS Wales for the treatment of previously untreated and relapsed follicular lymphoma, marginal zone lymphoma and Waldenstrom’s macroglobulinaemia under the following circumstances:

• In the first-line setting, for use in fit patients with aggressive follicular lymphoma and marginal zone lymphoma where other licensed and health technology appraisal-approved regimens are unsuitable.
• In the relapsed setting, for use in patients with follicular lymphoma and marginal zone lymphoma where other licensed and health technology appraisal-approved regimens are unsuitable.
• For the treatment of Waldenstrom’s macroglobulinaemia for first-line and relapsed disease in patients deemed unsuitable for anthracycline-based regimens and/or where other licensed and health technology appraisal-approved regimens are unsuitable.

The risks and benefits of the off-label use of bendamustine plus rituximab for this indication should be clearly stated and discussed with the patient to allow informed consent.

Providers should consult the relevant guidelines on prescribing unlicensed medicines before any off-label medicines are prescribed.

This advice will be reviewed after 12 months or earlier if new evidence becomes available.