Novartis’ Glivec at the centre of side effects study

Glivec (imatinib), the Novartis drug used to treat chronic myeloid leukaemia and gastrointestinal stromal tumours, has been found to cause hypophosphatemia in some patients, according to the results of a new study.

Hypophosphatemia is a deficiency of phosphate, an electrolyte needed for the operation of several processes in the body. Scientists from the Memorial Sloan-Kettering Cancer Centre studied 24 patients in total and monitored their levels of phosphate, among other factors. They concluded: “Hypophosphatemia, with associated changes in bone and mineral metabolism, develops in a proportion of patients taking imatinib for either chronic myelogenous leukaemia or gastrointestinal stromal tumours.”

“The drug may inhibit bone remodelling (formation and resorption), even in patients with normal serum phosphate levels,” adds the report.

Novartis told Reuters it described these bone side-effects in prescription information as being very infrequent, and added that the study was not statistically significant.

Dr Daniel Vasella, Novartis chairman and chief executive officer, said: “Glivec has an unprecedented record of efficacy and safety for the treatment of patients suffering from chronic myeloid leukaemia, allowing many to resume their daily lives.”

“The success of Glivec gives us confidence in the search for novel medicines that offer improved treatment outcomes,” he concluded.

Glivec was first approved by the FDA in 2001 and recent data shows that the survival rate in the first 4.5 years of the drug was 90 per cent. In 2005, Novartis submitted Glivec to the EU and US for treatment of various types of cancer.

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