First pre-operative breast cancer drug approved

For the first time, the U.S. Food and Drug Administration (FDA) has approved a medication for a pre-surgical treatment of breast cancer.

The drug – called Perjeta – is intended for patients with HER-2 positive breast cancer, an aggressive form of the disease with a high recurrence and death rate. It was initially approved in 2012 for advanced or late-stage breast cancer treatment.

Perjeta was granted accelerated pre-surgical approval based on a study showing women who received the drug as an initial treatment were more likely to be cancer-free 12 weeks later compared to women who received older drug combinations.

However, a larger follow-up study is being required by the FDA to provide further information on efficacy, safety and long-term outcomes. Results are expected in 2016.

Experts hope that pre-surgical medication could result in less invasive surgeries and improve survival rates. Typically, surgery has been the first step in breast cancer treatment.

“We are seeing a significant shift in the treatment paradigm for early stage breast cancer,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a news release. “By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.”

Breast cancer is the second most deadly form of cancer among women and is expected to kill more than 39,000 Americans this year, according to the National Cancer Institute. Almost 20 percent of those deaths will be attributed to the HER-2 form of the disease.

“Breast cancer is highly treatable when it’s discovered in its earliest stage,” said Virginia Friesen, RN, Director of the Cancer Institute at Advocate Condell Medical Center in Libertyville, Ill. “Regular screenings are essential so that the disease can be caught and treated as early as possible.”

The American Cancer Society recommends women age 40 and older have a mammogram every year and should continue to do so for as long as they are in good health.

For more information about breast health, visit StoriesoftheGirls.com.