Advice

following a resubmission considered under the orphan medicine process:

obinutuzumab (Gazyvaro®) is not recommended for use within NHSScotland.

Indication under review: obinutuzumab in combination with chemotherapy, followed by obinutuzumab maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma.

In a phase III study, obinutuzumab decreased the risk of disease progression compared with another monoclonal antibody in a subgroup of patients with previously untreated advanced follicular lymphoma.

The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

Medicine details

Medicine name:
obinutuzumab (Gazyvaro)
SMC ID:
SMC2015
Indication:
In combination with chemotherapy, followed by maintenance therapy in patients achieving a response, for the treatment of patients with previously untreated advanced follicular lymphoma (FL).
Pharmaceutical company
Roche
BNF chapter
Malignant disease and immunosuppression
Submission type
Resubmission
Status
Not recommended
Date advice published
10 September 2018