Obinutuzumab

Obinutuzumab (Gazyvaro, Roche Registration GmbH) has 5 EU-approved indications in 2 tumour types.
Approved indications of Obinutuzumab
Biomarker requirementRegimenSettingConditions
Chronic lymphocytic leukaemia1
None
+ chlorambucil
1L
Comorbidities making them unsuitable for full-dose fludarabine based therapy
Follicular lymphoma4
None
+ chemotherapy
1L
advanced
Then maintenance monotherapy
None
Monotherapy
Maint.
advanced
After Gazyvaro in combination with chemotherapy achieving a response
None
Monotherapy
Maint.
After Gazyvaro in combination with bendamustine without progression; did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
None
+ bendamustine
2L
Then maintenance monotherapy; Did not respond or progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen
Full text of section 4.1 (therapeutic indications)

Chronic lymphocytic leukaemia (CLL) Gazyvaro in combination with chlorambucil is indicated for the treatment of adult patients with previously untreated CLL and with comorbidities making them unsuitable for full-dose fludarabine based therapy (see section 5.1). Follicular lymphoma (FL) Gazyvaro in combination with chemotherapy followed by Gazyvaro maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced FL (see section 5.1) Gazyvaro in combination with bendamustine followed by Gazyvaro maintenance is indicated for the treatment of patients with FL who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen. Lupus nephritis (LN) Gazyvaro in combination with mycophenolate mofetil (MMF) is indicated for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis (LN).

Label history

21 changes to the Gazyvaro label since 2016, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes