The Food and Drugs Administration is in full support of approving a new Roche drug that will be used to treat early breast cancer.
The U.S. Food and Drugs administration has voiced its support in approving a new drug by Roche to treat early breast cancer. If approved, the drug will become the first FDA approvded drug to treat early stages of the disease.
The administration panel of cancer experts voted in favor of the drug 13-0, with one absentee. The benefits of the drug named Perjeta were said to outweigh its risks. Though the result of the votes is not final, it takes the FDA one step closer to approving the drug. It will be the first pharmaceutical option capable of shrinking tumors before surgery.
Swiss drug-maker Roche Holding AG's Genentech unit tested the drug on a few women and found that those who received the drug were 18 percent more likely to be free of cancerous tumors in 12 weeks when compared to other women that were given other older drugs combination.
Perjeta has already been approved for treating breast cancer but Genentech is now looking to sell the drug as the first step in treating the disease. Currently, cancer specialists use many drug combinations to treat the disease but none of them are officially approved.
"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.
Doctors hope that the new drug can help shrink tumors, making them easier to remove. This, in turn will allow some breast cancer women to keep their breasts even after surgery instead of undergoing a full mastectomy.
Though the FDA is all for approving the drug, members have stressed that Genentech would have to conduct a few trials to prove that Perjeta does result in longer life expectancy for patients. Complying with the FDA's request, the company is now conducting a follow-up trial using 4,800 patients who have already had surgery, Reuters reported.
The FDA did point out a few shortcomings of Perjeta's including a higher risk of heart diseases among patients taking the drug.
Breast cancer is the second most deadly form of cancer in U.S. women, and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute. About 6,000 to 8,000 deaths per year are attributed to the HER-2 form of the disease.
The disease is highly treatable when detected early. More than 98 percent of women who are diagnosed with first-stage breast cancer survive at least five years, according to NCI figures.
