Bristol-Myers Squibb Co., which makes Ixempra, said was the drug is approved for use with the chemotherapy drug capecitabine (brand name Xeloda) for treatment of women with breast cancer that's spread to other parts of the body.
The federal agency has given Ixempra a priority review status which is given to products that are considered to be an advance over existing therapies on the market.
The drug, which belongs to a new class of drugs called epothilones, will be available "within days," states Bristol-Myers Squibb.
Ixempra is approved for patients with metastatic or locally advanced breast cancer whose tumors don't respond to other breast cancer chemotherapy drugs.
The drug stops the growth of cancer cells by targeting a protein called tubulin that helps cells proliferate. Ixempra may be used alone or in combination with the chemotherapy drug Xeloda.
The FDA approved Ixempra based on two studies that included nearly 880 patients with advanced beast cancer, Bristol-Myers Squibb said.
The most common side effects associated with the drug include pain, fatigue, nausea, vomiting, and diarrhea. Also, the drug should not be used in patients with a history of heart disease, during pregnancy or in patients with liver problems.
