Currently, there is only one mAb — Herceptin — available for the two indications. Primarily marketed for breast cancer, Herceptin gained approval from the US Food and Drug Administration for the treatment of gastric and esophageal cancers in 2010. However, its patent is expected to expire in the European Union in 2014 and in the US by 2019.
Dominic Trewartha, Analyst for GBI Research, says: “Overall, Herceptin is able to improve survival times to a significant extent when compared with chemotherapy alone, without adding a substantial amount of side effects or safety concerns in Human Epidermal growth factor Receptor-2 (HER-2) positive patients. However, its efficacy is not sufficient to bring about a sustained remission in most cases of advanced disease, or to replace conventional chemotherapy completely in earlier stages.”
The pipeline for both indications is moderate, with 33 mAbs for gastric cancer and eight for esophageal cancer. The late-stage pipelines also include a number of novel drugs that have shown some clinical and commercial potential. However, none of these products are anticipated to offer significant improvements over existing therapies.
“There is still a need for stronger products with superior efficacy to treat both gastric and esophageal cancers in the metastatic and early settings periods. Also, with a large HER-2 negative patient population that is not eligible for treatment with Herceptin, there is a strong unmet need and opportunity for therapies that are effective in these patients, including those who overexpress HER-2,” Trewartha concludes. For more details please visit http://www.reportstack.com/