neratinib (Nerlynx)
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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
- small-molecule irreversible tyrosine kinase inhibitor of epidermal growth factor receptor
More general terms
Additional terms
References
- ↑ 1.0 1.1 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/20142587 <Internet> http://jco.ascopubs.org/content/28/8/1301
- ↑ 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 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/25287822 <Internet> http://jco.ascopubs.org/content/early/2014/10/03/JCO.2014.56.3809 - ↑ 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
- ↑ 4.0 4.1 4.2 4.3 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 - ↑ 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: https://www.ncbi.nlm.nih.gov/pubmed/26874901