Herceptin (trastuzumab)

Company
Genentech

Approval Status
Approved October 2010

Treatment for
gastric cancer

Possible similar drugs
Herceptin

Areas
Gastrointestinal , Cancer & Oncology

Herceptin (trastuzumab) is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein (HER2). HER2 is a cell membrane surface-bound receptor tyrosine kinase and is normally involved in the signal transduction pathways leading to cell growth and differentiation. HER2 is overexpresed in certain cancers.

Herceptin is specifically indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction enocarcinoma, who have not received prior treatment for metastatic disease.

Herceptin is supplied as a solution for intravenous administration. The recommended initial dose of Herceptin for gastric cancer is 8 mg/kg as a 90 minute intravenous infusion followed by subsequent doses of 6 mg/kg as an intravenous infusion over 30-90 minutes every three weeks until disease progression.

FDA Approval
The FDA approval of Herceptin for gastric cancer was based on an open-label, multi-center trial in 594 patients with HER2 gene amplified or overexpressing cancer who were not previously treated for metastatic gastric or gastroesophageal junction adenocarcinoma. The subjects received Herceptin administered in combination with cisplatin and a fluoropyrimidine (FC+H) or chemotherapy alone (FC). The Herceptin arm received an IV infusion at an initial dose of 8 mg/kg followed by 6 mg/kg every 3 weeks until disease progression. In both study arms, cisplatin was administered at a dose of 80 mg/m2 Day 1 every 3 weeks for 6 cycles as a 2 hour IV infusion and capecitabine was administered at 1000 mg/m2 dose orally twice daily (total daily dose 2000 mg/m2) for 14 days of each 21 day cycle for 6 cycles. Alternatively continuous intravenous infusion (CIV) 5-fluorouracil was administered at a dose of 800 mg/m2/day from Day 1 through Day 5 every three weeks for 6 cycles. The primary endpoint was overall survival. The final overall survival analysis based on 351 deaths was statistically significant. In the FC arm, 62.2% of the subjects had passed versus 56% in the FC+H arm (p=0.0193). A follow-up analysis was conducted one year after the final analysis. At this timepoint, in the FC arm 76.7% of the subjects had passed versus 74.2% in the FC+H arm.

Adverse events associated with the use of Herceptin for gastric cancer may include, but are not limited to, the following:

  • neutropenia
  • diarrhea
  • fatigue
  • anemia
  • stomatitis
  • weight loss
  • upper respiratory tract infections
  • fever
  • thrombocytopenia
  • mucosal inflammation
  • nasopharyngitis
  • dysgeusia
  • Herceptin (trastuzumab) is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein (HER2). HER2 is a cell membrane surface-bound receptor tyrosine kinase and is normally involved in the signal transduction pathways leading to cell growth and differentiation. HER2 is overexpresed in certain cancers.

    For additional information regarding Herceptin or gastric cancer, please visit the Herceptin web page.

    Herceptin_1121 Drug Information

    The Herceptin_1121 drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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