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.

Trastuzumab is in a class of medications called monoclonal antibodies. It works by stopping the growth of cancer cells. Trastuzumab emtansine treats breast cancer. This type of cancer happens when cells in the breast grow and divide in an uncontrolled way. A healthcare provider will give this medication via infusion into your vein in a hospital or clinic setting.

Trastuzumab emtansine binds to the HER2 receptor's sub-domain IV and goes into the cell by receptor-mediated endocytosis. Lysosomes degrade trastuzumab emtansine and release DM1. DM1 binds to tubulin in microtubules and inhibits microtubule function producing cell arrest and apoptosis.

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.

After detailed deliberation, the committee recommended conducting the Phase III clinical trial as per the protocol presented by the firm.

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