FDA Panel Backs Wider Use of Breast Cancer Drug
Perjeta, which seems to shrink early stage tumors, might gain quick FDA approval
"Pertuzumab was FDA approved in 2012 for the treatment of metastatic breast cancer when it was shown that it improved survival when added to standard regimens for HER2-positive metastatic breast cancer," Tiersten said. Metastatic breast cancer is cancer that has spread to other parts of the body.
"But the really exciting information is when this can be translated into earlier stages of disease, where we can completely eradicate the disease and cure more women," she said.
The preliminary trial under discussion showed that when Perjeta was added to standard pre-surgical regimens for HER2-positive breast cancer, the chance of finding no cancer after the treatment was nearly doubled, Tiersten said.
Women who have chemotherapy before surgery and who achieve complete remission -- no cancer at the time of breast surgery -- have a much greater chance of being completely cured of their disease, she said.
Dr. Aye Moe Thu Ma, attending physician in breast surgical oncology with St. Luke's and Roosevelt Hospitals in New York City, also voiced enthusiasm.
"We currently have limited options for [first-step] treatment of breast cancer," Ma said. "I'm excited that this may provide a more specific treatment for people with HER2-positive cancer."
This means women may be able to keep their breasts because the tumor size is reduced before surgery, and some women may prefer this, she said.
Genentech is hoping for fast-track approval of Perjeta. The FDA can expedite approval for groundbreaking drugs as long as the drug maker pursues more research to show that the medication prolongs disease-free survival.
Both short- and long-term side effects will need to be examined to fully evaluate risks and benefits of this medication if it is approved, Ma added.
Perjeta is one of many newer biologic agents used to treat breast cancer. "These biologic or 'targeted' treatments work on breast cancer cells in a more specific way than some older treatments so there are many fewer casualties to normal cells translating into many fewer side effects for our patients," Tiersten said.
About one in eight women in the United States will develop breast cancer in her lifetime.