2 The technology

2 The technology

Description of the technology

Obinutuzumab (Gazyvaro, Roche Products) is a type 2 glyco-engineered antibody that binds to the CD20 protein present on B cells, except stem or plasma cells, and causes cell death.

Marketing authorisation

Obinutuzumab has a marketing authorisation in the UK in combination with bendamustine, followed by obinutuzumab maintenance, for the treatment of patients with follicular lymphoma 'who did not respond or who progressed during or up to 6 months after treatment with rituximab or a rituximab-containing regimen'.

Adverse reactions

Common adverse reactions are upper respiratory tract infection, sinusitis, urinary tract infection, nasopharyngitis, oral herpes, rhinitis, pharyngitis, lung infection and influenza. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Obinutuzumab is given by intravenous infusion.

Induction:

  • Cycle 1: 1,000 mg on day 1, day 8 and day 15 of the first 28‑day treatment cycle

  • Cycles 2 to 6: 1,000 mg on day 1 of each 28‑day treatment cycle.

Maintenance:

  • 1,000 mg every 2 months for 2 years or until disease progression (whichever occurs first).

Price

£3,312 per 1,000‑mg vial (excluding VAT; British national formulary [BNF] edition 71).

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of obinutuzumab, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence.

The commercial arrangements included in the managed access agreement will be operationalised as a patient access scheme, agreed with the Department of Health.

  • National Institute for Health and Care Excellence (NICE)