First pre-surgery breast cancer drug approved by FDA

October 1, 2013 | By | Reply More

Oct 01, – The US Food and Drug Administration (FDA) has approved the first drug to be used in early stage breast cancer treatment. Perjeta (pertuzumab) will be used as part of a complete treatment regimen for patients before surgery (neoadjuvant setting).

hromedia First pre-surgery breast cancer drug approved by FDA health and fitness2Perjeta was approved by the European Union in 2012 for the treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer.

HER2-positive breast cancers have increased amounts of the HER2 protein that contributes to cancer cell growth and survival.

Breast cancer is the second leading cause of cancer-related death among women in the US.

An estimated 232,340 women will be diagnosed with breast cancer, and 39,620 will die from the disease in 2013, according to the National Cancer Institute.

Almost 20% of breast cancers have increased amounts of the HER2 protein.

Results of a new


by the Institute of Cancer Research in London and the


of Dundee highlighted “critical gaps” in breast cancer research, further emphasizing the need for immediate action.

Dr. Hal Barron, chief medical officer and head of Global Product Development at Roche, the company behind Perjeta, said:

“A new approval pathway has made Perjeta available to people with HER2-positive early breast cancer several years earlier than previously possible. Together with the FDA, we’ve charted new territory. We look forward to working with health authorities around the world to explore additional ways to bring promising medicines to patients more quickly.”

Early access to treatments

Under the FDA’s accelerated approval program, patients are provided access to promising drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted.

Perjeta can be prescribed to 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.

It is to be used in combination with trastuzumab and other chemotherapy prior to surgery and, depending upon the treatment regimen used, may be followed by chemotherapy after surgery.

Following surgery, patients should continue to receive trastuzumab to complete 1 year of treatment.

Medical News Today spoke with Dr. Charles Vogel, an internationally renowned breast cancer physician with the University of Miami’s Sylvester Comprehensive Cancer Center, about the efficacy of the drug.

He said that although surgery was still required, in some of his cases, the pre-surgery treatment has converted a patient from needing a mastectomy to only needing a lumpectomy – a significant improvement.

Achieving pathologic complete response

Perjeta’s accelerated approval for neoadjuvant treatment is based on a study designed to measure pathologic complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes.

In the study, 417 participants were randomly assigned to receive one of four neoadjuvant treatment regimens:

  Trastuzumab plus docetaxel

  Perjeta plus trastuzumab and docetaxel

  Perjeta plus trastuzumab, or

  Perjeta plus docetaxel.

About 39% of participants who received Perjeta plus trastuzumab and docetaxel achieved pCR, compared with about 21% who received trastuzumab plus docetaxel.

The confirmatory trial for this accelerated approval is being conducted in participants with HER2-positive breast cancer who had prior breast cancer surgery and are at high risk of having their cancer return.

More than 4,800 participants are enrolled in this trial, which will provide further data on efficacy, safety and long-term outcomes. Results are expected in 2016.

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

The most common side effects reported in participants receiving Perjeta plus trastuzumab and docetaxel were hair loss, diarrhea, nausea and a decrease in infection-fighting white blood cells.

Other significant side effects included decreased cardiac function, infusion-related reactions, hypersensitivity reactions and anaphylaxis.

Written by Belinda Weber

Health and science for HRO media – Dr. Ricardo Carlos, contributed to this report.

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Category: Health and Fitness

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