UK patients experiencing a relapse of chronic lymphocytic leukaemia have been given a new lifeline after regulators extended the license of Roche’s Mabthera granting all patients with this most common form of the disease access to the drug.
MabThera (rituximab) in combination with chemotherapy was first approved back in March for use in patients previously untreated for CLL – also winning favour with cost regulators for first-line use on the National Health Service – but has now also been given the green light for relapsed and difficult-to-treat (refractory) patients.
CLL affects more than 20,000 people in the UK and the availability of a new treatment option for the estimated two-thirds that will relapse “offers a vital lifeline” to these patients, commented Professor Andrew Pettitt, Consultant Haematologist at Royal Liverpool University Hospital and REACH trial investigator. “The ultimate goal”, he explained, “is to get them back into the best remission possible, and [MabThera] with chemotherapy achieves this for twice as many patients compared with chemotherapy alone”.
CLL is caused by the uncontrolled division of abnormal B-cells, and as these altered cells are unable to play their designated role in the immune system the body’s ability to fight infection is left compromised. MabThera targets a specific protein found on the surface of both healthy and malignant mature B-cells and then destroys them, which allows a new generation of healthy B-cells to develop from stem cells without harming other ‘healthy’ cells nearby.
Clinical trials have clearly demonstrated the drug’s potential benefits to patients, as 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 the proportion of patients experiencing complete remission was more than twice that of chemotherapy alone (36% vs 17.2%).
Indeed, the drug is widely hailed as a major advance in the treatment and management of the condition. As Professor John Gribben, Consultant Haematologist and Medical Oncologist at Barts and The London NHS Trust, previously noted: “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”.
