[ZEN GNE] U.S. FDA panel reviews new breast cancer therapies
Wednesday September 2, 12:54 pm Eastern Time
By Alicia Ault
WASHINGTON, Sept 2 (Reuters) - A U.S. Food and Drug Administration advisory panel on Wednesday began considering the first preventive treatment for breast cancer.
The FDA's Oncologic Drugs Advisory Committee will weigh whether tamoxifen, an existing breast cancer treatment made by British-based Zeneca Group Plc (quote from Yahoo! UK & Ireland: ZEN.L), is safe as a preventive measure for women at high risk for the disease.
The FDA panel was also due to consider Genentech Inc.'s (GNE - news) Herceptin, a unique new drug that uses antibodies to disrupt the growth of a common type of breast tumor.
The panel is expected to make a recommendation later on Wednesday on whether to approve the two therapies for use in the United States. The FDA usually follows the panel's advice.
Data released in April from one of the largest cancer prevention studies ever showed that tamoxifen almost halved the chance of getting breast cancer in healthy women who had many risk factors, such as a family history of the disease.
A groundbreaking study by the National Cancer Institute (NCI) and the National Surgical Adjuvant Breast and Bowel Project found tamoxifen was so effective in reducing breast cancer risk that the trial was halted 14 months early.
But it is unclear whether tamoxifen can be taken safely for long periods.
Women in the study took the drug for up to five years and had a higher risk of getting uterine cancer. Thirty-three of the 6,700 women taking tamoxifen got uterine cancer, compared to only 14 of the 6,700 taking a placebo.
Women taking tamoxifen also had a higher risk of blood clots, including dangerous clots that migrate to the lungs.
But with 180,000 new cases of breast cancer in the United States each year, many women may choose to take the drug. The preventive regimen is expected to cost $80 to $100 a month.
Genentech's Herceptin is a monoclonal antibody, a genetically engineered version of one of the body's own disease-fighting agents. It binds to the HER2 receptors in breast cancer cells that seem to play a role in regulating tumor growth.
About 25-30 percent, or 60,000 cases, of breast cancer in the United States each year are the type that overexpresses HER2.
In studies, 49 percent of women with advanced, metastatic breast cancer given Herceptin along with a chemotherapy drug had their tumors shrink by at least half, compared to 32 percent of women taking chemotherapy alone.
The greatest response was in women taking Herceptin with Bristol-Myers Squibb Co.'s (BMY - news) taxol.
The main side effects included fever and chills, but there was a risk of heart complications when Herceptin was taken with the anthracycline class of tumor-fighting drugs.
Herceptin is on a fast-track review, which means it could be launched this year if it gets final FDA backing. |
