Skip to Content

Tykerb Approval History

  • FDA approved: Yes (First approved March 13th, 2007)
  • Brand name: Tykerb
  • Generic name: lapatinib ditosylate
  • Dosage form: Tablets
  • Company: GlaxoSmithKline
  • Treatment for: Breast Cancer

Tykerb (lapatinib) is a kinase inhibitor indicated for the combination treatment of patients with advanced or metastatic breast cancer.

Development History and FDA Approval Process for Tykerb

Feb  1, 2010Approval GSK's Tykerb Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer
Mar 13, 2007Approval FDA Approves Tykerb (lapatinib) in Combination With Xeloda (capecitabine) for the Treatment of Advanced or Metastatic Breast Cancer in Women Who Have Progressed on Prior Therapy
Sep 18, 2006GlaxoSmithKline Seeks U.S. Approval for Tykerb (lapatinib ditosylate) for the Treatment of Advanced Breast Cancer

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.