Tykerb/Xeloda is now FDA approved. TYKERB is indicated in combination with Xeloda® (capecitabine) for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and Herceptin® (trastuzumab). Therefore, the request for Tykerb 250MG OR TABS should be approved for therapy for a duration of 12 months.
According to Eustace, A. J. et al. (2019), “Lapatinib has clinical efficacy in the treatment of trastuzumab-refractory HER2-positive breast cancer. However, a significant proportion of patients develop progressive disease due to acquired resistance to the drug. Induction of apoptotic cell death is a key mechanism of action of lapatinib in HER2-positive breast cancer cells.”
Per LiverTox (2019). “Lapatinib is a small molecule inhibitor of several tyrosine kinase receptors involved in tumor cell growth that is used in the therapy of advanced breast cancer and other solid tumors. Lapatinib therapy is associated with transient elevations in serum aminotransferase levels and rare instances of clinically apparent acute liver injury.”
Finaly, Petrelli, F. et al. (2017), “Breast cancer (BC) with HER-2/neu overexpression or amplification (HER-2+) is associated with a higher prevalence of brain metastases (BMs) when compared to other subtypes. Among approved drugs for HER-2+ BC, lapatinib (L) is associated with single agent activity toward BMs. We conducted a systematic review to determine the efficacy of L, singly or in combination with capecitabine (C), as a treatment for HER-2+ BMs.”
Eustace, A. J., Conlon, N. T., McDermott, M., Browne, B. C., O’Leary, P., Holmes, F. A., Crown, J. (2018). Development of acquired resistance to lapatinib may sensitise HER2-positive breast cancer cells to apoptosis induction by obatoclax and TRAIL. BMC cancer, 18(1), 965. doi:10.1186/s12885-018-4852-1
LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Lapatinib. [Updated 2019 May 15]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547971/
Petrelli, F., Ghidini, M. et al. (2017).The efficacy of lapatinib and capecitabine in HER-2 positive breast cancer with brain metastases: A systematic review and pooled analysis.Eur J Cancer. 2017 Oct;84:141-148. doi: 10.1016/j.ejca.2017.07.024. Epub 2017 Aug 12.Format: AbstractSend