EU approves Herzuma for HER2 metastatic gastric cancer.- Celltrion.
Celltrion announced that the European Commission (EC) approved Herzuma (trastuzumab biosimilar) for the treatment of patients with metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on December 14, 2017.
Herzuma will be available as a 150 mg powder for concentrate for solution for infusion. The active substance of Herzuma is trastuzumab, a monoclonal antibody (ATC code: L01XC03) that binds with high affinity and specificity to HER2 leading to the inhibition of proliferation of tumour cells that overexpress HER2.
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