Celltrion's Herzuma (Trastuzumab Biosimilar- CT-P6) Receives EMA Approval for Breast Cancer- Metastatic Breast Cancer and Metastatic Gastric Cancer
Shots:
- The approval is based on positive opinion by CHMP (EMA) assessing Herzuma and reference trastuzumab in patients with HER2 overexpression/gene amplification tumors in breast cancer- metastatic breast cancer and metastatic gastric cancer
- The study resulted in a non-inferiority data demonstrating efficacy- safety- immunogenicity- PD and PK in patients
- Herzuma (trastuzumab biosimilar- CT-P6) is a mAb- that binds to extracellular domain of human epidermal growth factor receptor (HER2) and is currently reviewed by FDA review in the USS
Ref: Celltrion | Image: Celltrion
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