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.

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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