New Breast Cancer Therapy Fast-tracked by FDA

Promising breast cancer drug therapy approved quickly

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There’s more encouraging news in the battle against breast cancer. 

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The first pre-surgical drug treatment to treat early stages of breast cancer has been approved by the U.S. Food and Drug Administration (FDA). Availability of the treatment was fast-tracked on the FDA’s accelerated approval program. The quick approval was based on promising results of a study that showed its effectiveness as part of a neoadjuvant (combined) therapy.

The FDA approved the use of the drug pertuzumab (brand name PERJETA®) — used in combination with other drugs — to treat patients with locally advanced breast cancer before surgery.

A large, multicenter study of 417 women showed that the new therapy — combining pertuzumab, trastuzumab (Herceptin®) and the chemotherapy drug docetaxel — resulted in 39.3 percent of patients achieving absence of invasive cancer in the breast and lymph nodes.

In comparison, only 21.5 percent of patients who were treated with this regimen — but without pertuzumab— achieved this result.

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‘Paradigm shift’ in approval process makes new therapy available

“This is a paradigm shift in the drug approval process,” says Jame Abraham, MD, who was not involved in the study but is an oncologist at Cleveland Clinic.

“This approach will substantially shorten the clinical trial process and allow us to bring highly effective treatments to the patient sooner,” Dr. Abraham says. “Potentially this will encourage clinical investigators and pharmaceutical companies to direct their resources to this approach for studying new drugs.”

Promising treatment for most aggressive breast cancer

The drug’s new use is for patients with HER2-positive, locally advanced, inflammatory or early-stage breast cancer, who are at high risk of having their cancer return, spread, or of dying from the disease.

Pertuzumab was first approved in 2012 for treatment of advanced or late-stage HER2-positive breast cancer. It is a targeted therapy that searches for and attacks the HER2 receptor on cancer cells. HER2-positive breast cancer is the most aggressive form of the disease.

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“This is a very specific targeted treatment,” says Dr. Abraham. “It’s really promising.”

Potential benefits of accelerated approval

Under the FDA’s accelerated approval program, patients can receive therapies to treat serious or life-threatening illnesses even while confirmatory clinical trials are still being conducted.

Though more research will be needed to further test the drug’s effectiveness and safety for pre-surgical use, high-risk patients now have a new tool available in their fight against breast cancer.

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