(RxWiki News) For the first time in its history, the US Food and Drug Administration has approved a medication for the pre-surgical (neoadjuvant) treatment of early-stage (I, II) breast cancer.
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The medication, which has been approved for the treatment of advanced or late-stage (metastatic) HER2-positive breast cancer, can now be used for patients with the following forms of breast cancer:
- HER2-positive breast cancer, an aggressive cancer which is characterized by an overexpression of the HER2 protein, which helps cancer cells grow and thrive
- Locally advanced breast cancer that has started to spread beyond the original tumor to nearby tissues or lymph nodes
- Inflammatory breast cancer, another difficult to treat form of the disease
- Early-stage breast cancers with tumors greater than 2 centimeters in diameter or that have spread to the lymph nodes
All of these breast cancers put the patient at higher risk of the cancer returning, spreading or causing death.
Chemotherapy may also be used following surgery, depending on the treatment regimen.
The new use of this drug was approved under the FDA’s accelerated approval program, which offers patients access to potentially beneficial medicines that treat serious or life-threatening diseases while clinical trials confirming benefits are still underway.
In the confirmatory trial, 417 participants were randomly assigned to receive one of four neoadjuvant treatment regimens — trastuzumab plus docetaxel (a chemotherapy agent sold under the brand name Taxotere), Perjeta plus trastuzumab and docetaxel, Perjeta plus trastuzumab or Perjeta plus docetaxel.
Researchers were looking for what they call “pathologic complete response (pCR),” meaning the absence of invasive cancer in the breast and lymph nodes.
About 39 percent of the participants taking Perjeta plus trastuzumab and docetaxel achieved pCR, compared to roughly 21 percent who received trastuzumab plus docetaxel.
"This is a step forward in the neoadjuvant treatment of high-risk early stage HER2-positive breast cancer," Adam Brufsky, MD, PhD, professor of medicine at the University of Pittsburgh School of Medicine, told dailyRx News.
“We are seeing a significant shift in the treatment paradigm for early stage breast cancer,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
“By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences," Dr. Pazdur said.
Another confirmatory trial involving more than 4,800 patients with HER2-positive breast cancer who’ve had surgery and are at high risk of recurrence is ongoing, with results expected in 2016.
The most common side effects for participants taking Perjeta plus trastuzumab and docetaxel were hair loss, diarrhea, nausea and a decrease in infection-fighting white blood cells.
Perjeta is marketed by Genentech, a member of the Roche Group, based in South San Francisco.