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CHMP Issues Positive Opinion on Herzuma for HER2+ Breast, Gastric Cancers

Jason Harris
Published: Monday, Dec 18, 2017

The European Union’s Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion for Herzuma (CT-P6), a trastuzumab (Herceptin) biosimilar, for the treatment of patients with HER2-positive early breast cancer, metastatic breast cancer, or metastatic gastric cancer.

Investigators observed TEAEs due to heart failure in 2% of patients in the Herzuma group and 1% of the trastuzumab group. Of these patients, only 1 patient in the trastuzumab group was withdrew from the study.
Stebbing J, Baranau Y, Baryas V, et al. CT-P6 compared with reference trastuzumab for HER2-positive breast cancer: a randomised, double-blind, active-controlled, phase 3 equivalence trial. Lancet Oncol. 2017; 18: 917-928. doi: 10.1016/S1470-2045(17)30434-5.

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