FDA United in Approval of Roche Drug for Early Breast Cancer

The Food and Drugs Administration in unison supported Roche drug as an effective treatment for early stage of breast cancer.

The FDA voted 13-0, with one no vote, that the drug named Perjeta has more benefits than risks in treating early breast cancer. The drug would be the first FDA approved drug to treat the disease, if approved.

The drug is supposed to be first pharmaceutical option capable of shrinking tumors before surgery. Roche Holding AG's Genentech, a Swiss drug-maker, tested the drug on a few women and the results showed that those who received the drug were 18 percent more likely to be free of breast cancer tumor in 12 weeks compared to women that were given other older drugs.

The drug, Perjeta, has already received a nod to treat breast cancer that spreads to different parts of the body. But the company now wants an approval to market the drugs as the first step in treating the disease, reported the Associated Press.

"We are supporting the movement of a highly active drug for metastatic breast cancer to the first-line setting, with the hope that women with earlier stages of breast cancer will live longer and better," panel chairman Dr Mikkael Sekeres, an associate professor of medicine at the Cleveland Clinic, told New York Times.

According to the doctors, the drug will help in reducing the tumors allowing them to be removed with ease. It will also help in preventing full mastectomy.

But the FDA members maintained that  Genentech will need to conduct a few trials to prove that Perjeta does result in longer life expectancy for patients. Following this, the company will conduct a follow-up trial using 4,800 patients who have already had surgery, Reuters reported.

In the U.S. breast cancer is the second most leading cause of death among women and will kill around 39,000 more women this year, according to the National Cancer Institute. The statistics show that 98 percent of women who were diagnosed and treated at an early stage survived at least five years.