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NICE gives new blood cancer drug ‘obinutuzumab’ the green light

written by

Leukaemia Care, Charity

  • carer

NHS patients with chronic lymphocytic leukaemia (CLL) could soon be able to access obinutuzumab, following the draft guidance by the National Institute for Health and Care Excellence (NICE).

CLL is the most common form of leukaemia in adults, with most patients diagnosed over the age of 60. It 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. CLL is a very slowly developing disease and it is often not possible to cure.

NICE have today provisionally recommended the use of obinutuzumab in combination with chlorambucil chemotherapy for the treatment of previously-untreated adult patients with CLL and co-existing  medical conditions who are unsuitable for full-dose fludarabine-based therapy and only if bendamustine-based therapy is not suitable. Obinutuzumab is marketed by Roche as Gazyvaro®.

Obinutuzumab has previously been licenced by the European Medicines Agency (EMA) and this NICE draft guidance represents the next step forwards for patient access in the NHS in England and Wales. However, this draft guidance is only provisional and hopefully should soon be followed by NICE’s final guidance, which will determine whether obinutuzumab is available as a treatment on the NHS.

Obinutuzumab works in two ways. Firstly triggering ‘direct cell death’; by causing B-cells to self-destruct when they come into contact with obinutuzumab. Secondly by ‘marking’ cancerous cells, this enables the immune system cells to target and destroy cancer 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.

Monica Izmajlowicz, Leukaemia CARE Chief Executive, said: “We welcome this draft NICE guidance as a positive step forward towards NHS patient access of obinutuzumab, which appears to offer patients an improvement over their current treatment options. Following the NICE draft guidance, we eagerly await the final guidance and hope that NICE recommend the use of obinutuzumab.”