FDA approves Bristol-Meyers drug

Source: Healthcare Digital

Date :17/10/2007 09:28:18

A new chemotherapy drug called Ixempra made by Bristol-Myers Squibb Co for women with advanced breast cancer has won U.S. approval to be sold.

Ixempra, a chemotherapy drug designed to kill cancer cells, is part of a new class called epothilones.

The U.S. Food and Drug Administration said on Tuesday it approved Ixempra as a stand-alone treatment for patients with advanced tumors that do not respond to Roche Holding AG's Xeloda or drugs known as anthracyclines or taxanes.

It also was cleared for use with Xeloda certain advanced breast cancer patients.

Among patients who took Ixempra with Xeloda in clinical trials, tumors either shrank or did not grow for an average of 5.8 months, compared to 4.2 months seen for patients taking only Xeloda.

Ixempra

For most patients the total cost of a full course of Ixempra is expected to run from $18,440 to $23,050, Bristol-Myers spokesman Tony Plohoros said.

Two ongoing trials are expected to determine by late 2008 whether Ixempra actually extends survival.

According to FDA spokesman Christopher DiFrancesco, potential side effects from Ixempra include tingling or numbness in the hands and feet, bone-marrow suppression, constipation, nausea, vomiting, muscle pain, joint pain, fatigue and weakness.

The new drug which is expected to be available in days is known generically as ixabepilone and could generate annual sales of $500 million by 2012.

October 17 2007

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