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FDA Approves First Pre-Surgical Breast Cancer Drug

Update Date: Oct 01, 2013 10:54 AM EDT

The U.S. Food and Drug Administration on Monday approved a biotech drug “Perjeta” which can be used to tread breast cancer before surgery. With this approval the biotech drug has become the first medicine of such kind.

Perjeta is made by Roche’s Genentech Unit. It would be a feasible option for women with early stage breast cancer. Earlier surgery was normally the first step in treating most forms of cancer.

Doctors are quiet positive about the decision by FDA. They hope that using cancer drugs prior could help shrink those tumors. Smaller tumors are often easier to remove.

Cancer specialist already are using other chemotherapy drugs for initial treatment for cancer. However these are not formally approved for the use.

“We are seeing a significant shift in the treatment paradigm for early stage breast cancer,” said Richard Pazdur, M.D., 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.’’

Doctors also say that the treatment of the disease at its earliest stages could also prevent tumors from returning. Though a study is yet to establish this benefit.

‘‘This does not yet prove to us that using the antibody in this setting will result in more cures.’’ Dr. Paula Klein, a cancer specialist, who also directs the breast cancer program at Continuum Cancer Centers of New York.

The approval by FDA is based on 417-women study comparing Perjeta in different combinations against older breast cancer treatments.

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