CHMP Favors Kadcyla Approval in EU for Certain HER2-positive Early Breast Cancer Patients

CHMP Favors Kadcyla Approval in EU for Certain HER2-positive Early Breast Cancer Patients
The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended that Kadcyla (ado-trastuzumab emtansine) be approved as an adjuvant (post-surgery) treatment for certain HER2-positive early breast cancers, the treatment's maker, Genentech, has announced. Specifically, the advisory committee for the European Union’s regulatory agency is recommending Kadcyla's approval for patients who still have residual disease in their breast or lymph nodes after receiving pre-surgery treatment with a taxane and HER2-targeted therapy, such as trastuzumab. In the coming months, the European Commission is expected to decide whether or not to expand the existing marketing authorization for Kadcyla in the EU, based on CHMP’s recommendation. The U.S. Food and Drug Administration granted the treatment
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