pertuzumab biosimilar / Intas - LARVOL DELTA

Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Pertuzumab Biosimilar for Breast Cancer (Medical Dialogues) - "Intas Pharmaceuticals has received approval from the Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), to conduct a Phase III clinical trial for its biosimilar of the anti-cancer drug Pertuzumab. The approval follows the company’s presentation of a protocol for a Phase III study titled: 'A Prospective, Randomized, Double-Blind, Parallel-Arm, Comparative, Phase III Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of Pertuzumab Biosimilar of Intas Pharmaceuticals Limited Against Perjeta in Adult Patients with HER2-Positive Hormone Receptor-Negative Locally Advanced or Early Breast Cancer', submitted for export purposes under Protocol No. 0508-23, Version 1.0, dated 18 Oct 2024."

New P3 trial • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer