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Tykerb FDA Approval History

FDA Approved: Yes (First approved March 13, 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 timeline for Tykerb

Jan  4, 2024Lapatinib Increases Overall Survival in Metastatic Breast Cancer Patients With HER2-Positive Circulating Tumor Cells
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 BreastCancer 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

Further information

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