FDA Approves First Pre-surgery Breast Cancer Drug

The Food and Drug Administration (FDA) approved the first pre-surgery breast cancer drug Monday.

Called Perjeta, the medication was approved in 2012 for the treatment of patients with last-stage HER2-positive breast cancer, or breast cancers with increased amounts of the HER2 protein, which contributes to the growth and survival of cancer cells. Nearly 20 percent of breast cancers exhibit increased amounts of the HER2 protein.

The new approval will allow for its use as part of "a complete treatment regimen" for those with early stage breast cancer, according to an FDA statement, and is to be used along with chemotherapy prior to surgery.

The announcement represents a significant step in new approach in treating the deadly disease, according to Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

"We are seeing a significant shift in the treatment paradigm for early stage breast cancer," he said. "By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.''

Under the agency's accelerated approval program, patients are allowed access to the drug in order to treat "serious or life-threatening conditions" even as confirmatory trials are underway.

Perjeta's accelerated approval is based on a study including more than 400 patients, each randomly assigned one of four pre-surgery treatments. Thirty-nine percent of participants who received Perjeta in addition to the drug Herceptin and standard chemotherapy saw their cancer reach undetectable levels, compared to 21 percent of women receiving Herceptin and chemotherapy alone.

A confirmatory study has already enrolled 4,800 patients, the results of which are expected in 2016.

Breast cancer is the second leading cause of cancer-related death among women, according to the National Cancer Institute. An estimated 232,340 women will be diagnosed before the end of the year. Meanwhile, 39,620 are estimated to die from the disease.