EirGenix Report Results of EG12014 (biosimilar, trastuzumab) in P-III Trial for HER2-Positive Breast Cancer

March 25, 2021 Auto Bot Biosimilars, P-III Trial, Report, results, trastuzumab 0

Shots:

  • The P-III trial involves assessing the safety, immunogenicity and PK of EG12014 (trastuzumab, biosimilar) vs Herceptin in 807 patients in a ratio (1:1) for HER2-positive breast cancer
  • The trial met its 1EPs showed equivalent efficacy to Herceptin in regards to clinical response (pCR) in both analysis populations (per-protocol and full-analysis sets) and demonstrated a comparable safety profile in the pre-operative treatment setting
  • The company is preparing to submit BLA to the US FDA, MAA to EMA and NDA to TFDA

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Novatek International

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