lenalidomide (Revlimid)

following a full submission considered under the orphan process

lenalidomide (Revlimid®) is accepted for restricted use within NHS Scotland.

Indication under review: treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

SMC restriction: for use in patients unsuitable for thalidomide-containing regimens

Continuous lenalidomide plus low-dose dexamethasone, compared with melphalan, prednisolone plus thalidomide, significantly improved progression-free survival in treatment-naive patients with newly diagnosed multiple myeloma who were not eligible for transplant. Overall survival data are immature, but interim analyses suggest a survival benefit for lenalidomide plus low-dose dexamethasone compared with melphalan, prednisolone plus thalidomide.

This submission focuses on lenalidomide in combination with dexamethasone. Lenalidomide is also licensed for use in combination with melphalan and prednisolone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. The submitting company did not provide evidence for SMC assessment therefore SMC cannot recommend this combination for use in this treatment setting.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.