A breast cancer drug made by Roche is on the verge of becoming the first approved medicine to treat patients before surgery, ABC News reported.
A panel of cancer experts from the Food and Drug Administration (FDA) voted 13-0, with one abstention, that the benefits of Perjeta outweighed the risks as an initial treatment for breast cancer on Thursday. If Perjeta is approved for the market, it would be the first medical option to reduce or eliminate tumors before surgery.
Roche Holding AG's Genetech unit conducted a study that demonstrated women who took Perjeta as initial treatment were 18 percent more likely to be cancer-free after 12 weeks than women who took other drugs.
The Swiss drugmaker has already gotten Perjeta approved to treat cancer that has spread to other parts of the body, known as metastatic cancer, but now is seeking approval for it to be used as the first part to treating the disease.
Panel chairman Dr. Mikkael Sekeres described the 13-0 vote as "a historic moment."
"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," said Sekeres, an associate professor of medicine at the Cleveland Clinic.
Doctors hope that Perjeta will help shrink the size of tumors and therefore make surgical removal easier, possibly allowing women in some cases to keep their breasts rather than having a mastectomy. Some specialists have been using chemotherapy as the first step to treatment although it is not formally approved to do so.
In addition to expressing their excitement over Perjeta, some panelists urged caution in moving forward until the drug proves itself to extend life expectancy for patients.
"I look forward to the day several years from now when we can say that this improves survival," said Dr. Louis Diehl of Duke University Medical Center. "But if it doesn't, I think we should stand up and say we did the very best we could today, but it didn't work out."
