Swiss drugmaker Novartis has submitted its cancer drug Glivec/Gleevec (imatinib) for a new indication, a rare form of leukaemia, after reporting clinical data showing that it provides a significant improvement in progression-free survival.

Novartis has filed in Europe to expand the use of Glivec to include the treatment of adults with Philadelphia chromosome-positive acute lymphoblastic leukaemia, either alone or in combination with chemotherapy. Around 2,500 new cases of Ph+ ALL are reported each year in Europe and the USA.

If approved, Glivec would be the first therapy that specifically targets the genetic abnormality responsible for the disease, said Novartis. The product will be filed for Ph+ ALL before the end of the year in the USA.

The submissions are based on clinical data which demonstrated two-year disease free survival of up to 87% and one-year overall survival of up to 84% for newly diagnosed Ph+ ALL patients taking Glivec alongside a standard chemotherapy regimen. According to figures from the US National Cancer Institute, just 35%-40% of ALL patients survive two years or more with aggressive chemotherapy, and the prognosis is poorer for those with the Ph+ mutation.

Novartis is a key growth product for Novartis in its currently-approved uses of chronic myeloid leukaemia and gastrointestinal stromal cancers. Despite being approved for relatively rare cancers, the drug still managed to achieve sales of $1.58 billion dollars in the first nine months of this year.

Separately, Novartis reported updated results of the landmark IRIS study of Glivec, showing that more than 90% of patients with a Ph+ CML continue to survive and are free from progressing to advanced disease after four and a half years of treatment.

Femara effective post-tamoxifen

Meanwhile, new clinical results for Novartis’ cancer drug Femara have revealed that the drug has ‘dramatic’ benefits for women with breast cancer, even after a prolonged period of no treatment.

This is the first time that a drug in the aromatase inhibitor class has demonstrated a benefit in starting therapy up to five years after the end of a patient taking tamoxifen, currently the first-line medicine used in the treatment of oestrogen-sensitive breast cancers, Novartis said.

The data, a new analysis of the landmark MA-17 trial, showed that postmenopausal women who switched from placebo to Femara were 47% less likely to die, experienced a 69% reduction in the recurrence of breast cancer, and a 72% reduction in the risk that the cancer would metastasise to a distant part of the body.

"The findings may have a substantial impact on the overall treatment outcomes for postmenopausal women with early breast cancer," said Dr Paul Goss of the Massachusetts General Hospital in Boston and the lead investigator of the MA-17 trial.

Femara recently received approval in the UK for the adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer. Approval for the adjuvant indication is expected in the USA before the end of 2005 and in other countries in 2006, said Novartis.