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FDA Approves First Pre-Surgical Breast Cancer-Fighting Drug

Feb 16, 2017

The US Food and Drug Administration (FDA) approved a biotech drug from Roche, offering an earlier approach to treat breast cancer before surgery. Perjeta, approved by the European Union in 2012, is now available to patients in the US.

A New First Step

Typically the first step to fight most forms of cancer is surgery to remove tumors. Perjeta can be prescribed as part of a cancer treatment program prior to surgery to help prevent cancer from spreading and decrease tumor size. Perjeta is an inhibitor of HER-2, a protein overproduced in about 20 percent of breast cancer patients with tumors. This overproduction of the HER-2 protein rapidly increases tumor growth.

Perjeta is intended for “patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) who are at high risk of having their cancer return or spread (metastasize) or of dying from the disease,” according to an FDA press release. The drug is approved under the FDA’s accelerated approval program, making it available to patients while clinical trials to confirm the results and determine the long term effects will be ongoing. Results are anticipated by 2016.

The 417-women study showed patient’s cancer reaching undetectable levels increases 18 percent when using the new drug in conjunction with chemotherapy and Herceptin (trastuzumab), compared to the results of using chemotherapy and Herceptin alone.

Not Quite the Solution

Surgery is still required as part of the treatment program with the new drug. However, in some cases, the patient only needs a lumpectomy instead of a mastectomy. While Perjeta doesn’t eliminate surgery altogether, it can provide a dramatic improvement in the invasiveness of the surgery required. This new drug lays claim to first in the industry, helping to improve the treatment breast cancer.