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FDA Approves Nerlynx for Adjuvant BC Treatment
FDA news release; 2017 July 17
The FDA has approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer.
Indications: Nerlynx is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
Dosage and administration: 240 mg given orally once daily with food, continuously for 1 year. Reduce starting dose to 80 mg in patients with severe hepatic impairment.
Efficacy and safety: Approval is based on a randomized trial of more than 2,800 individuals showing that 94% of patients treated with Nerlynx had not experienced cancer recurrence or death, vs 92% of those given placebo.
Side effects/risks: The most common adverse reactions are diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, decreased weight, and urinary tract infection.
FDA approves new treatment to reduce the risk of breast cancer returning. [news release]. Silver Spring, MD: FDA. July 17, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567309.htm. Accessed July 29, 2017.
Nerlynx [package insert]. Los Angeles, CA: Puma Biotechnology, Inc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208051s000lbl.pdf. Accessed July 29, 2017.