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Nerlynx, a new treatment for the extended adjuvant treatment of early-stage HER2-positive breast cancer: FDA approved

The FDA ( U.S. Food and Drug Administration ) has 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.

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% 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.
After two years, 94.2% of patients treated with Nerlynx had not experienced cancer recurrence or death compared with 91.9% 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 ( hepatotoxicity ), 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. ( Xagena )

Source: FDA, 2017