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NICE approve new CLL treatment

written by

Leukaemia Care, Charity

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The National Institute for Health and Care Excellence (NICE) has today approved idelalisib for NHS patients within England and Wales. Idelalisib is marketed as Zydelig® by the pharmaceutical company Gilead and will be used to treat patients with chronic lymphocytic leukaemia (CLL).

CLL is a slowly developing form of leukaemia which affects a type of white blood cell known as B lymphocytes, which makes antibodies to help fight infection. Blood cells are formed in the bone marrow (which is the spongy tissue found inside bones) and divide to produce either more stem cells or immature cells that become mature blood cells over time. In CLL the bone marrow produces too many B lymphocytes which are not fully developed. These cells fill up the bone marrow, preventing it from producing normal, healthy cells. Idelalisib works by regulating this cellular activity. There are around 3,200 new cases of CLL in the UK each year, with approximately 2,950 patients diagnosed in England and Wales.

NICE has recommended idelalisib “in combination with rituximab” for “untreated chronic lymphocytic leukaemia in adults with a 17p deletion or TP53 mutation or for chronic lymphocytic leukaemia in adults when the disease has been treated but has relapsed within 24 months.” The recent decision to approve idelalisib was made following an agreement to reduce the cost of the drug. The results of several clinical trials also contributed as they concluded that idelalisib improved progression-free survival. Additionally, it was shown to improve overall response to treatment, lymph-node response and overall survival.

NICE have concluded that idelalisib (in combination with rituximab) is an innovative therapy as it has the potential to make a significant and substantial impact to patient outcomes. It concluded that the drug offered a “step change in the treatment” options for CLL, presenting patients with an effective alternative to the limited existing therapies.

Monica Izmajlowicz, Leukaemia CARE Chief Executive, has commented:

“This recent NICE recommendation is excellent news for patients with chronic lymphocytic leukaemia and for CLL patients with 17p or TP53 mutation in particular. The decision to approve this innovative and effective treatment option is welcome progress for patients with previously limited treatment options.”