trastuzumab emtansine biosimilar
/ Intas
- LARVOL DELTA
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April 26, 2024
Intas Pharmaceuticals Gets CDSCO Panel Nod To Study Trastuzumab Emtansine In Metastatic Breast Cancer
(Medical Dialogues)
- "In a significant development, Intas Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III study to evaluate the efficacy, safety, immunogenicity, and pharmacokinetics of Trastuzumab Emtansine biosimilar compared with Kadcyla in HER2- Positive Unresectable Locally Advanced or Metastatic Breast Cancer patients who have received prior treatment with Trastuzumab and a Taxane....At the recent SEC meeting for Oncology held on the 3rd and 4th of April 2024, the expert panel reviewed the proposal to conduct a Phase III clinical trial study of Trastuzumab Emtansine Powder for concentrate for solution for Infusion 100mg/vial and 160 mg/vial presented by Intas Pharmaceutical."
New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor
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