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

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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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