trastuzumab emtansine biosimilar / Intas - LARVOL DELTA

Ahmedabad-based Intas Pharmaceuticals has secured the Central Drugs Standard Control Organisation (CDSCO) approval to market a biosimilar of the blockbuster cancer therapy, Trastuzumab Emtansine in India. (The Economic Times) - "The drug is approved to treat both early- and advanced-stage HER2-positive breast cancer in patients previously treated with trastuzumab (an immunotherapy) and taxane- (a chemotherapy drug)...Intas' approval is supported by positive results from a local Phase 3 trial conducted by the firm to establish the efficacy, safety, immunogenicity and pharmacokinetics of its formulation. The approval covers two strengths —100 mg and 160 mg— both to be administered intravenously (IV)."

Approval • HER2 Positive Breast Cancer

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