Breast Cancer Cases Soar Among Those Under 50

First Breast Cancer Drug Perjeta Gets FDA Approval

A new breast cancer drug has been approved by the Food Drug Administration, the first of its kind on the market for treatment ahead of surgery for breast cancer.

The new breast cancer drug approved for use before surgery is Perjeta (pertuzumab), and the FDA detailed the drug’s release and approval in a press announcement on their site.

According to the FDA, the breast cancer drug was brought to market quickly, due to its efficacy and lack of other options for pre-surgical drug therapies:

“The U.S. Food and Drug Administration today granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer… Perjeta was approved in 2012 for the treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer. HER2-positive breast cancers have increased amounts of the HER2 protein that contributes to cancer cell growth and survival.”

The FDA’s new breast cancer drug announcement explains that Perjeta is marketed for patients diagnosed with “HER2-positive, locally advanced, inflammatory or early stage breast cancer… who are at high risk of having their cancer return or spread (metastasize.)”

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said of Perjeta in the release that the drug was a new tool in keeping cancer from coming back:

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

Side effects of the new breast cancer drug have been observed as possibly including hair loss, diarrhea, nausea, immune system suppression, decreased cardiac function, infusion-related reactions, hypersensitivity reactions, and anaphylaxis.