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Drugs Before Surgery

Posted 10/1/2013

Posted in

  Over the past years, there has been an increasing use of "neoadjuvant" treatment for women with newly diagnosed breast cancer. This means that some women have received chemotherapy before surgery (obviously, after a biopsy) in an attempt to shrink the tumor and eventually allow a lumpectomy rather than a mastectomy. In my clinical experience, this has often been successful, and I have known many women whose treatment was planned in this way.

  The drugs used in neoadjuvant chemotherapy have been the standard drugs that are generally delivered after surgery. Now the FDA has approved the first drug, Perjeta, to be used for women who are her2 positive prior to surgery. This feels important as a next step in a changing field.

  Here is the start of an article from Consumer Healthday and then a link to read more:

FDA Approves First 'Pre-Surgical' Drug for Breast Cancer
Perjeta, which seems to shrink early-stage tumors, can now be used before surgery

MONDAY, Sept. 30 (HealthDay News) -- The U.S. Food and Drug Administration on Monday approved the first drug to be used before the surgical treatment of breast cancer.

Perjeta (pertuzumab), which was granted accelerated approval by the FDA, is already used to treat breast cancer in its advanced stages. This is the first time that women with early-stage HER2-positive breast cancers -- a typically aggressive form of tumor -- will have the chance to start treatment with something other than surgery, the agency said.

The hope is that pre-surgical treatment could result in less invasive surgeries and improved survival rates. Typically, surgery has been the first step in breast cancer treatment.

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

An FDA advisory panel had voted unanimously earlier this month to recommend approval of broader use of the drug. An agency report had said the drug looked promising in trials, but added that drug-related cardiac concerns required additional research.


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