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neratinib (Nerlynx)

Indications: - adjunct treatment of metastatic breast cancer - used in combination with capecitabine [1] - FDA-approved for reducing risk of recurrence of HER2- positive early breast cancer initially treated with trastuzumab [4] Dosage: - 240 mg PO QD (6 40 mg tablets) with food for 1 year [4] - maximum 240 mg/day - take with loperamide (Imodium) for 1st 60 days [4] Tabs: 40 mg Adverse effects: - in combination with capecitabine - diarrhea (88%) - hand-foot syndrome (48%) Mechanism of action: 1) small-molecule irreversible tyrosine kinase inhibitor of epidermal growth factor receptor

Related

chemotherapy for breast cancer

General

small inhibitory antineoplastic agent (ib drug)

References

  1. Burstein HJ et al Neratinib, an Irreversible ErbB Receptor Tyrosine Kinase Inhibitor, in Patients With Advanced ErbB2-Positive Breast Cancer. J Clin Oncol March 10, 2010 vol. 28 no. 8 1301-1307 PMID: 20142587 http://jco.ascopubs.org/content/28/8/1301
  2. Gradishar WJ Neratinib for Metastatic HER2 Breast Cancer. NEJM Journal Watch. Nov 3, 2014 Massachusetts Medical Society (subscription needed) http://www.jwatch.org - Saura C et al. Safety and efficacy of neratinib in combination with capecitabine in patients with metastatic human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol 2014 Oct 6 PMID: 25287822 http://jco.ascopubs.org/content/early/2014/10/03/JCO.2014.56.3809
  3. FDA Briefing Document. May 24, 2017 Oncologic Drugs Advisory Committee Meeting NDA 208051. Neratinib. Applicant: Puma Biotechnology, Inc https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM559721.pdf
  4. FDA News Release. July 17, 2017 FDA approves new treatment to reduce the risk of breast cancer returning. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm567309.htm - Windle ML. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review Medscape - Jan 11, 2018. https://reference.medscape.com/viewarticle/890871 - U.S. Food and Drug Administration. Novel Drug Approvals for 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm537040.htm
  5. Chan A, Delaloge S, Holmes FA et al Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):367-77. Epub 2016 Feb 10. PMID: 26874901