Intas Pharmaceuticals Gets CDSCO Panel Nod to Study Trastuzumab Emtansine in Metastatic Breast Cancer
New Delhi: 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.
This came after Intas Pharmaceuticals presented the proposal to conduct a Phase III clinical trial study titled “A prospective, randomized, open-label, parallel group, active-controlled, multicenter, Phase III study to evaluate the efficacy, safety, immunogenicity, and pharmacokinetics of proposed 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” vide protocol No. 0198-23 version No.: 1.1, dated 03- Jan-2024.
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