FDA Gives First Approval to Pre-Surgical Breast Cancer Drug

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On Monday, the FDA gave its first approval to a pre-surgical breast cancer drug. The drug, Perjeta, manufactured by Roche had been previously approved for late-stage breast cancer last year. Accelerated approval of the drug for treating pre-surgical breast cancer was given following a recent study that showed women who received the drug as an initial treatment were more likely to be free of cancer within 12 weeks earlier than those receiving prevalent drug combinations for treating breast cancer.

In early September, FDA scientists had positively reviewed the drug a few days before a panel of independent cancer specialists reviewed the benefits of Perjeta against risks of its use. The external panel voted 13-0 and the panel chairman, Dr. Mikkal Sekeres called the vote “a historic moment.”

  

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Earlier in September, CBS News contributor Dr. David Agus, of the Westside Cancer Center at the University of Southern California said on CBS This Morning that Perjeta was “an exciting drug because it targets a particular pathway in the cancer – an ‘on’ switch if you will. About 15,000 women a year have this very aggressive cancer with … (a molecule called HER-2) and it turns it off.”

The FDA based its approval on a 417-woman study that compared Perjeta in different combinations against prevalent drug combinations for breast cancer. When combined with Herceptin and standard chemotherapy, the cancer went down to undetectable levels in 39 percent of the women.

Perjeta is not a blanket treatment for all kinds of breast cancer, but is targeted towards breast cancer that is triggered by the protein HER-2.

Dr. Richard Pazdur, the director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, after approving Perjeta for pre-surgical breast cancer treatment, said, “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.”