National Health Service doctors in Scotland have been given the go ahead to prescribe Roche’s cancer drug MabThera (rituximab) for patients with chronic lymphocytic leukaemia, the most common form of the disease.

Specifically, the Scottish Medicines Consortium has approved the use of MabThera as a first-line attack on CLL alongside a chemotherapy mix of fludarabine and cyclophosphamide, after concluding that such a regimen is a cost-effective use of NHS resources.

The news offers new hope to the estimated 1,850 patients in Scotland with CLL, as the drug has been shown in clinical trials to significantly extend progression free survival and boost the number of patients achieving complete disease remission, according to Roche.

CLL is form of blood cancer caused by the uncontrolled division of abnormal B-cells, which play a vital role in the body’s defence system. These ‘damaged’ B-cells are unable to function properly, and as their multiplication takes over that of healthy B-cells it hampers the immune system’s ability to fight infection. CLL can spread to the lymph nodes, central nervous system and other organs in the body, but does not normally form a tumour.

MabThera is a monoclonal antibody that targets a protein expressed on the surface of both healthy and malignant mature B-cells and destroys them, thereby allowing a new generation of healthy B-cells to develop from stem cells.

The existing standard treatment for most patients with CLL is chemotherapy, but as this also kills other types of healthy cells around the cancer its effectiveness is limited by how much the patient can tolerate. However, adding MabThera - which targets only B-cells – to the treatment regimen has the potential to markedly improve outcomes.

Significant benefits
In clinical trials the addition of MabThera to fludarabine/cyclophosphamide chemotherapy extended progression-free survival by 10.5 months versus chemotherapy alone (3.5 years vs 2.7 years), and that the number of patients achieving complete remission was more than twice that of chemotherapy alone (36% vs 17.2%), clearly demonstrating its potential benefits to patients with the disease.

It is estimated that more than 20,000 people in the UK are living with CLL and that there will be around 3,700 new cases every year, highlighting the urgent need for novel and more effective treatments. According to Tony Gavin, Director of Campaigning and Advocacy, Leukaemia CARE, the addition of MabThera “can result in a better quality and longer-lasting remission, allowing people to return to work and enjoy family life with reduced symptoms”.

A spokesperson for Roche told PharmaTimes UK News that a course of MabThera for the treatment of CLL will cost the NHS £9,000, and is given once every 28 days for a total of six cycles. But all eyes will now be on the National Institute for Health and Clinical Excellence, the SMC’s sister cost watchdog for England and Wales, which is currently reviewing MabThera and is due to publishing its recommendations by the end of the month.