In the preliminary guidance, uncertainties in the company’s data mean that the committee proposes not to recommend obinutuzumab combination therapy for people who are not able to take the standard fludarabine-based therapy.

CLL is a type of cancer that affects the cells in the bone marrow (where blood cells develop) and causes overproduction of abnormal white blood cells. The abnormal white blood cells replace the normal cells in the bone marrow but are unable to function properly. Signs and symptoms can include fatigue, breathlessness, bruising and bleeding. The condition can develop slowly with many people not suffering any symptoms at all in the early stages. Obinutuzumab works by attaching itself to the surface of abnormal white blood cells, which then causes the cells to die.

Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: “Chronic lymphocytic leukaemia is the most common form of leukaemia in the UK, with around 2,700 people being diagnosed with the condition each year. Half of the people who need treatment for their condition are not able to use the standard first-line therapy.  NICE recommended alternative treatments are already available.

“Although obinutuzumab is a clinically effective treatment, there were too many uncertainties in the company’s submission and we cannot be confident that it is an effective use of NHS resources. It is disappointing that we are not able to add this to the range of treatments already available. However, with limited resources we need to ensure that each treatment we recommend gives patients not only the best care but is also of the best value to the NHS.”

For more details, go to: https://www.nice.org.uk/news/press-and-media/data-uncertainties-mean-nice-does-not-recommend-leukaemia-drug-in-draft-guidance