2 Information about obinutuzumab
Marketing authorisation indication
2.1 Obinutuzumab (Gazyvaro, Roche) 'in combination with chemotherapy, followed by [obinutuzumab] maintenance therapy in patients achieving a response, is indicated for the treatment of patients with previously untreated advanced follicular lymphoma'.
Dosage in the marketing authorisation
2.2 Obinutuzumab is given by intravenous infusion. Induction consists of obinutuzumab plus chemotherapy dosage:
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with cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) or cyclophosphamide, vincristine and prednisolone (CVP):
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cycle 1: 1,000 mg on days 1, 8 and 15 of the first 21‑day treatment cycle
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cycles 2 to 8: 1,000 mg on day 1 of each 21‑day treatment cycle (with the CHOP regimen, obinutuzumab is given alone for the last 2 cycles), or
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with bendamustine:
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cycle 1: 1,000 mg on days 1, 8 and 15 of the first 28‑day treatment cycle
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cycles 2 to 6: 1,000 mg on day 1 of each 28‑day treatment cycle and
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maintenance dosage of 1,000 mg every 2 months for 2 years or until disease progression (whichever occurs first).
Price
2.3 £3,312 per 1,000‑mg vial (excluding VAT; BNF online, August 2017). The company has a commercial arrangement. This makes obinutuzumab available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.