FDA OKs Herceptin for Early Breast Cancer （ZT）

Recurrences Cut in Half, Studies Show

November 29, 2006 10:33:03 AM PST

Yahoo! Health: Breast Cancer News

The breast cancer drug Herceptin (trastuzumab) is now officially available to women with early-stage disease. The US Food and Drug Administration approved the drug for this use earlier this month, though many women had already been receiving the treatment off-label. The drug was previously approved only for women with breast cancer that had spread to other parts of the body (metastatic cancer).

The approval follows the publication last year of study results showing Herceptin could cut breast cancer recurrences in half when given to women with early-stage tumors. Those findings led many doctors to prescribe the drug to women with early breast cancer even though it was not officially approved for that use.

Now, women with cancer that has not spread beyond the breast or lymph nodes can get Herceptin along with chemotherapy after surgery to remove the tumor. However, the drug is only effective -- and can only be used -- in women whose tumors have too much of the protein HER2/neu. These tumors tend to be more aggressive. About 15%-25% of breast tumors have too much HER2.

The FDA also limited Herceptin's use to women who do not have heart failure or weak heart muscle (cardiomyopathy). That's because the drug can weaken the heart muscle and cause heart failure that must then be treated. Women who want to take Herceptin will have to be screened for heart function before and during treatment, the FDA said.

Other potential side effects include chills, fever, and shortness of breath, sometimes with lung problems, and low white and red blood cell counts.

Herceptin, made by Genentech, is given in a doctor's office through an infusion into a vein. For early-stage cancer it is typically given every week for a year.