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Obinutuzumab, sold under the brand name Gazyva among others, is a humanized anti-CD20 monoclonal antibody used as a treatment for cancer and active lupus nephritis. It was originated by GlycArt Biotechnology AG and developed by Roche.
Read the full article on WikipediaChronic lymphocytic leukaemia (CLL) Clinical criteria: Treatment Phase: Combination use with chlorambucil only The condition must be CD20 positive, AND The condition must be previously untreated, AND The treatment must be in combination with chlorambucil, AND The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition. Treatment must be discontinued in patients who experience disease progression whilst on this treatment.
Stage II bulky or Stage III/IV follicular lymphoma Clinical criteria: Treatment Phase: Maintenance therapy Patient must have previously received PBS-subsidised treatment with this drug under the previously untreated initial restriction, AND The condition must be CD20 positive, AND Patient must have demonstrated a partial or complete response to PBS subsidised induction treatment with this drug for this condition, AND The treatment must be maintenance therapy, AND The treatment must be the sole PBS-subsidised therapy for this condition, AND The treatment must not exceed 12 doses or 2 years duration of treatment, whichever comes first, under this restriction, AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Follicular lymphoma Clinical criteria: Treatment Phase: Re-induction treatment Patient must not have previously received PBS-subsidised obinutuzumab, AND The condition must be CD20 positive, AND The condition must be refractory to treatment with rituximab for this condition, AND The condition must be symptomatic, AND The treatment must be for re-induction treatment purposes only, AND The treatment must be in combination with bendamustine, AND The treatment must not exceed 8 doses for re-induction treatment with this drug for this condition. The condition is considered rituximab-refractory if the patient experiences less than a partial response or progression of disease within 6 months after completion of a prior rituximab-containing regimen. A patient may only qualify for PBS-subsidised initiation treatment once in a lifetime under: i) the previously untreated induction treatment restriction; or ii) the rituximab-refractory re-induction restriction.
Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) Clinical criteria: Treatment Phase: For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy The condition must be untreated, AND The treatment must be in combination with PBS-subsidised venetoclax.
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) Clinical criteria: Treatment Phase: Pre-treatment prior to initiation of glofitamab Patient must be eligible to receive treatment under the PBS listing criteria for glofitamab. Patient is intended to receive a single dose of Obinutuzumab 1000 mg 7 days prior to initiating glofitamab treatment (Cycle 1, Day 1).
“28.4 days”
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