The National Institute for Health and Clinical Excellence has given a green light for the use of Roche’s cancer drug MabThera on the National Health Service for patients with chronic lymphocytic leukaemia, the most common form of the disease.

Following in the footsteps of sister body the Scottish Medicines Consortium, which cleared use of the drug last month, the Institute says doctors in England and Wales can now also prescribe MabThera (rituximab) as a first-line therapy for CLL alongside a chemotherapy mix of fludarabine and cyclophosphamide, after concluding that such a regimen is a cost-effective use of NHS resources.

CLL is form of blood cancer caused by the uncontrolled division of abnormal B-cells, which play a key role in the body’s defence system. These altered B-cells are unable to function properly, and as their multiplication takes over that of their healthy counterparts the body’s ability to fight infection is compromised.

MabThera is a monoclonal antibody that works by targeting a specific protein found on the surface of both healthy and malignant mature B-cells and then destroying them. This allows the new generation of healthy B-cells to develop from stem cells without harming other ‘healthy’ cells nearby, as chemotherapy can.

The decision to endorse the use of MabThera on the NHS spells good news for the estimated 20,000 CLL patients in the UK today, as it essentially gives them free access to a treatment that can potentially double the chance of complete remission compared to the current standard of care of chemotherapy alone, the firm said.

Indeed, clinical trials have shown that adding MabThera to a mix of chemotherapy with fludarabine/cyclophosphamide extended progression-free survival by 10.5 months versus chemotherapy alone (3.5 years vs 2.7 years), and that proportion of patients experiencing complete remission was more than twice that of chemotherapy alone (36% vs 17.2%), clearly demonstrating its potential benefits to patients with the disease.

A ‘major advance’
According to Professor John Gribben, Consultant Haematologist and Medical Oncologist at Barts and The London NHS Trust, the ability to add MabThera to chemotherapy is “a major advance” in the treatment of CLL. “Where previously our goal was just to improve symptoms, for the first time we now have a treatment combination that is capable of producing much higher remission rates and more durable responses”, he explained.

Unsurprisingly Roche has also welcomed the decision. “CLL is a devastating disease that has no cure [but] longer, deeper remissions allow people to return to work and family life with reduced or eliminated symptoms,” commented John Melville, General Manager of Roche Products Ltd.