Bristol-Myers Squibb receives negative recommendation

Bristol-Myers Squibb has said its product Ixempra has received a negative recommendation from the Committee for Medicinal Products for Human Use.

Used for locally advanced or metastatic breast cancer, the about the drug comes despite a US Food and Drugs Administration (FDA) approval – granted in October 2007.

However, the committee cited safety concerns as the reason for its decision, with side effects noted included peripheral neuropathy, fatigue, nausea and anorexia.

The marketing application for the product was based on results from a randomised phase III trial, which saw patients with metastatic or locally advanced breast cancer treated with Ixempra, in combination with Roche’s Xeloda.

As a result of the research, there was an improvement in progression-free survival of 5.7 months, compared to 4.1 months for patients treated with Xeloda by itself.

Ixempra is a semi-synthetic analogue of epothilone B, designed to prevent or inhibit the development and growth of cancer cells.

Breast cancer in the most common form of the disease in women worldwide, with incidence in seven major markets forecast to be over 455,000 in 2008 – of which 43 per cent of the cases will be in the five main EU markets (can’t think of a way to avoid rep, there).

In other news, a drug marketed by Bristol-Myers Squibb and Sanofi-Aventis has been criticised by a study.

The research found Avapro didn’t benefit people with a certain type of heart failure.