Cancer Therapy Center

CBS News is one of many carrying the news about the FDA’s expanded approval of Herceptin for treating breast cancer.

The breast cancer drug Herceptin received expanded federal approval Thursday to include treatment of some women after they have undergone surgery.

In two clinical trials, women given the drug along with chemotherapy had fewer relapses in the three years after surgery — either to remove a lump or the whole breast — than those just given standard chemotherapy, the Food and Drug Administration said in announcing the additional approval. The drug is made by Genentech Inc. of South San Francisco, Calif.

In 1998, the FDA approved Herceptin to treat breast cancer after it had spread to other parts of the body. Thursday’s approval expands its use to women with cancer in the breast or lymph nodes that has been surgically removed, the FDA said.

Only patients with HER-2 positive tumors, and who do have heart failure or a weak heart, should be given the drug, also known as trastuzumab.

Swiss pharmaceutical company Roche Holding AG asked the European Medicines Agency to approve its drug, Herceptin, as a treatment for advanced breast cancer, the International Herald Tribune reports.

The application is based on a study that showed that “the addition of Herceptin to hormonal therapy doubles the median progression-free survival,” the company said in a statement.

HER2-positive breast cancer, which affects 20 percent to 30 percent of women with breast cancer, is an aggressive form of the disease that requires special attention because the tumors are fast-growing and there is a higher likelihood of relapse.

“This combination offers a new treatment regimen for patients who suffer from a particularly aggressive form of breast cancer, and we are pleased to have been able to progress this application so quickly,” said Eduard Holdener, Global Head of Roche Pharma Development.

Sales of Herceptin are up significantly in the first half of 2006, and expanded approval could allow sales to increase even more.