First pre-surgical breast cancer drug has been approved by the US Food and Drug Administration (FDA) and can be used during the early stages of breast cancer treatment.

The first pre-surgical drug approved is Perjeta (pertuzumab). Perjeta was approved by the European Union in 2012 for the treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer, according to Medical News Today.

With breast cancer being the second leading cause of cancer-related death among women in the U.S., the first pre-surgical drug is a way to help the survival rate.

An estimated 232,340 women will be diagnosed with breast cancer, and 39,620 will die from the disease in 2013, according to the National Cancer Institute.

Almost 20% of breast cancers have increased amounts of the HER2 protein, which is where the Perjeta comes in. It is a HER2/neu receptor antagonist compound. It has been shown to augment anti-tumor activity as a complement to Herceptin, as the two medicines target different regions on the HER2 receptor, according to medilexicon.com.

After a trial-run, it was determined that a study showed a 6.1 month improvement in median progression-free survival (PFS) in subjects treated with Perjeta, trastuzumab and docetaxel compared to those who received Herceptin and chemotherapy plus placebo.

Dr. Hal Barron, chief medical officer and head of Global Product Development at Roche, the company behind Perjeta, told Medical News:

"A new approval pathway has made Perjeta available to people with HER2-positive early breast cancer several years earlier than previously possible. Together with the FDA, we've charted new territory. We look forward to working with health authorities around the world to explore additional ways to bring promising medicines to patients more quickly."

Another study is ongoing and thus far, about 39% of participants who received Perjeta plus trastuzumab and docetaxel achieved pCR, compared with about 21% who received trastuzumab plus docetaxel. More than 4,800 participants are enrolled in this trial, which will provide further data on efficacy, safety and long-term outcomes. Results are expected in 2016.

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