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12
Dec
SMC approves obinutuzumab

written by

Leukaemia Care, Charity

  • SMC 2

Earlier this week the Scottish Medicines Consortium (SMC) accepted obinutuzumab for use within NHS Scotland.

Obinutuzumab has been accepted for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy. Common comorbidities include heart problems or kidney disease. Obinutuzumab is marked by Roche as Gazyvaro®.

CLL is the most common form of leukaemia in adults in the UK, with patients’ average age at diagnosis of over 60. It is a very slowly developing disease and it is often not possible to cure. CLL involves the body’s white blood cells becoming faulty and multiplying at a faster rate than normal, the excess abnormal cells prevent the immune system working properly, making patients more vulnerable to infections.

Obinutuzumab has a ‘double-pronged mode of attack’ which triggers ‘direct cell death’ by causing B-cells to self-destruct when they come into contact with it. Additionally, it also enables the immune system cells to target and destroy cancer cells by ‘marking’ cancerous cells. Data from the main clinical trial (CLL11) appears to show that obinutuzumab combined with chemotherapy reduces the risk of death, increases life expectancy and increases the chance of remission in comparison to using the current standard chemotherapy alone.

Obinutuzumab has previously been licenced by the European Medicines Agency (EMA) and the National Institute of Health and Care Excellence (NICE) recently issued draft guidance provisionally recommending the use of obinutuzumab, with final guidance to hopefully soon follow. The SMC decision appears to closely follow the NICE draft guidance recommending the use of obinutuzumab in England. To see our news article on the NICE draft guidance, please click here.

Monica Izmajlowicz, Leukaemia CARE Chief Executive, said: “We welcome this decision by the Scottish Medicines Consortium, which enables patients in Scotland to routinely access this treatment. We await the final guidance from NICE to see whether they will make the same decision.”