The U.S. Food and Drug Administration today granted accelerated
approval to Perjeta (pertuzumab) as part of a complete treatment regimen
for patients with early stage breast cancer before surgery (neoadjuvant
setting). Perjeta is the first FDA-approved drug for the neoadjuvant
treatment of breast cancer.
Perjeta was approved 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.
Perjeta’s new use is intended for 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 one year of treatment.
“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.’’
In May 2012, the FDA issued a draft guidance
about the use of pathologic complete response (pCR), defined as the
absence of invasive cancer in the breast and lymph nodes, as an endpoint
to support accelerated approval of a drug for neoadjuvant treatment of
high-risk, early stage breast cancer. 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’s accelerated approval for
neoadjuvant treatment is based on a study designed to measure pCR. 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 percent of participants who received Perjeta
plus trastuzumab and docetaxel achieved pCR, compared to about 21
percent 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.
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.
The
FDA reviewed Perjeta’s use for neoadjuvant treatment under the agency’s
priority review program, which provides for an expedited review of
drugs that may offer major advances in treatment.
Breast cancer
is the second leading cause of cancer-related death among women. 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 percent of breast cancers have increased amounts of
the HER2 protein.
Perjeta is marketed by Genentech, a member of the Roche Group, based in South San Francisco, Calif.
For more information:
FDA: Office of Hematology and Oncology Products
FDA: Approved Drugs: Questions and Answers
NCI: Breast Cancer
The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.
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