Novartis' groundbreaking cancer drug has been recommended for first-line treatment of chronic myeloid leukaemia (CML).

NICE has recommended Glivec for the treatment of Philadelphia-chromosome-positive CML, the most common form of the disease, and said patients could be switched to Glivec from the traditional first-line treatment, interferon-alpha, after a consultation with their doctor.

NICE also advised that Glivec could be used to treat the more advanced stages of Ph+ CML provided patients have not already received the drug.

Cancer and leukaemia-specific patients groups issued a joint press release praising the drug efficacy over the current standard treatment.

CancerBACUP, Cancer Research UK, CMLSupport.org, Leukaemia CARE, Leukaemia Research Fund and The Leukaemia Society (UK) said: "The assessment points in particular to data showing greater progression-free survival, fewer more manageable side effects and in consequence, a better quality of life, for patients treated with Glivec as a first line therapy in Ph+ CML."

Although only a preliminary recommendation, NICE said that all clinicians treating Ph+ CML in the chronic phase in England and Wales should review their work in line with the new guidance.

Novartis Oncology hopes that the final guidance issued by NICE in the autumn will follow this preliminary appraisal and that implementation will be encouraged across England and Wales at the earliest opportunity.

Estimates on the cost of the guidance to the NHS range from £2 to £6 million for the first year, rising to £15 to 20 million at five years, depending on the number of people eligible for its use and cost savings from avoided interferon-alpha treatment.

The guidance extends NICE's previous ruling on the drug, made last August, which only recommended Glivec in the chronic phase of the disease if patients had already failed to respond to interferon-alpha.

Glivec received another boost recently with the publication in the New England Journal of Medicine of research showing its efficacy.

A clinical trial showed that Glivec successfully treated the genetic cause of CML, a major goal of overall treatment, in 74% of patients, compared with 8% of patients using traditional drugs.

Datamonitor analysts said: "This is another step forward in confirming the drug efficacy and suggests that Glivec is on its way to becoming a blockbuster drug."

pharmafocus@pharmafile.co.uk