Sandoz gets EMA Committee positive opinion for breast, gastric cancer biosimilar trastuzumab

The impact of both breast and gastric cancers in Europe is significant. Each year, over 355,000 women are diagnosed with breast cancer and, with 92,000 deaths per year, it is the number one cause of cancer death among women. Gastric cancer is the sixth most common of all cancer types and, with 107,000 deaths annually, it is the fourth most common cause of cancer-related death in Europe. In up to 20% of breast cancers and up to 30% of gastric cancers diagnosed, an HER2 protein overexpression (or HER2 gene amplification) is detected resulting in an uncontrollable growth and division of cells. HER2 cancers are particularly aggressive cancer types that respond well to targeted treatment.

The comprehensive analytical, preclinical, and clinical data regulatory submission package included evidence derived from an extensive analytical characterization, in addition to results from a Phase I PK/PD study and a confirmatory Phase III study in breast cancer patients (EGC002). Both studies met their primary endpoints, confirming that the biosimilar matches the reference biologic in terms of pharmacokinetics as well as efficacy, safety and immunogenicity.

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