SILVER SPRING, Md.,
July 17, 2017 /PRNewswire-USNewswire/
-- The U.S. Food and Drug Administration today approved Nerlynx
(neratinib) for the extended adjuvant treatment of early-stage,
HER2-positive breast cancer. For patients with this type of cancer,
Nerlynx is the first extended adjuvant therapy, a form of therapy
that is taken after an initial treatment to further lower the risk
of the cancer coming back. Nerlynx is indicated for adult patients
who have been previously treated with a regimen that includes the
drug trastuzumab.
"HER2-positive breast cancers are aggressive tumors and can
spread to other parts of the body, making adjuvant therapy an
important part of the treatment plan," said Richard Pazdur, M.D., director of the FDA's
Oncology Center of Excellence and acting director of the Office of
Hematology and Oncology Products in the FDA's Center for Drug
Evaluation and Research. "Now, these patients have an option after
initial treatment that may help keep the cancer from coming
back."
Breast cancer is the most common form of cancer in the United States. The National Cancer
Institute (NCI) estimates approximately 252,710 women will be
diagnosed with breast cancer this year, and 40,610 will die of the
disease. According to the NCI, approximately 15 percent of patients
with breast cancer have tumors that are HER2-positive.
Nerlynx is a kinase inhibitor that works by blocking several
enzymes that promote cell growth.
The safety and efficacy of Nerlynx were studied in a randomized
trial of 2,840 patients with early-stage, HER2-positive breast
cancer who completed treatment with trastuzumab within the previous
two years. The study measured the amount of time after the start of
the trial that it took for the cancer to come back or for death to
occur from any cause (invasive, disease-free survival). After two
years, 94.2 percent of patients treated with Nerlynx had not
experienced cancer recurrence or death compared with 91.9 percent
of patients receiving placebo.
Common side effects of Nerlynx include diarrhea, nausea,
abdominal pain, fatigue, vomiting, rash, swollen and sore mouth
(stomatitis), decreased appetite, muscle spasms, indigestion
(dyspepsia), liver damage (AST or ALT enzyme increase), nail
disorder, dry skin, abdominal swelling (distention), weight loss
and urinary tract infection.
Patients should be given loperamide for the first 56 days of
treatment with Nerlynx and as needed thereafter to help manage
diarrhea. Additional antidiarrheals, fluids and electrolytes should
also be given as clinically indicated to help manage diarrhea.
Patients who experience severe side effects, including diarrhea or
liver damage (hepatoxicity), should stop taking Nerlynx. Women who
are pregnant or breastfeeding should not take Nerlynx because it
may cause harm to a developing fetus or a newborn baby.
The FDA granted the approval of Nerlynx to Puma Biotechnology
Inc.
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.
Media Inquiries: Angela
Stark, 301-796-0397, angela.stark@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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SOURCE U.S. Food and Drug Administration