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NICE backs GSK drug for leukaemia

Arzerra on course for NHS use in blood cancer
GSK Headquarters

The National Institute for Health and Care Excellence (NICE) has issued draft guidance recommending GlaxoSmithKline's Arzerra in a form of leukaemia.

NICE, which provides health guidance for the NHS in England and Wales, said the drug was a cost-effective option in combination with chlorambucil for untreated chronic lymphocytic leukaemia (CLL) in people who are not eligible for treatment with fludarabine combination therapy and for whom bendamustine is unsuitable.

The guidance only applies if GSK provides Arzerra (ofatumumab), which has a list price of £182 for 100mg or £1,820 for 10000mg, at a discount through a confidential patient access scheme.

Sir Andrew Dillon, NICE chief executive, said: “The key aim of first treatment for people with untreated chronic lymphocytic leukaemia is to prevent the disease from progressing and delay time to next treatment.

“The information provided by GlaxoSmithKline, who market the drug, showed that Arzerra with chlorambucil is a clinically effective treatment option for those people unable to take fludarabine combination therapy or bendamustine."

Arzerra works by attaching itself to the surface of B cells, a type of white blood cell that is overproduced in CLL. By doing so it activates the immune system to kill the cells.

The medicines is one of the cancer drugs due to be transferred from GSK to Novartis under an asset swap deal announced earlier this year.

Arzerra brought in lacklustre sales in the face of competition from Roche's MabThera/Rituxan (rituximab), which has the same molecular target, and more competition is due from Johnson & Johnson's Imbruvica (ibrutinib) following its approval in Europe last month.

GSK has retained rights to the subcutaneous formulation of ofatumumab – the active ingredient of Arzerra - and intends to develop it for a number of autoimmune diseases.

This includes the rare skin condition pemphigus vulgaris and relapsing, remitting multiple sclerosis.

Article by
Kirstie Pickering

4th November 2014

From: Sales



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