FDA APPROVES NEW INDICATION FOR GENENTECH'S HERCEPTIN

The FDA has expanded the approved use of Genentech's Herceptin, a cancer drug. The new indication is for using Herceptin, in combination with other cancer drugs, for the treatment of HER2-positive breast cancer after surgery (lumpectomy or mastectomy). FDA granted priority review to the supplemental application for Herceptin.

Herceptin is a targeted therapy against the HER2 protein on cancer cells. When an excessive amount of HER2 protein is present it causes cancer cells to grow more rapidly, and standard chemotherapy may be less effective. The FDA approved Herceptin in 1998 for the treatment of metastatic breast cancer. The new approval expands its use to women with cancer only in the breast or lymph nodes which has been removed with surgery.

The two studies leading to the new indication were conducted by the National Cancer Institute (NCI). Patients in both trials received standard chemotherapy after surgery for breast cancer; approximately half the patients were also given Herceptin. The results from both trials, which included information on nearly 4,000 women, were combined and analyzed in 2005.

Due to positive results, the NCI ended the studies early. The results showed that women who received Herceptin combined with chemotherapy had fewer relapses for up to three years after surgery. The estimated three-year disease-free rates were 87 percent in women receiving Herceptin and chemotherapy and 75 percent in those receiving chemotherapy alone.

The most serious side effect of Herceptin is heart failure that requires medical treatment.