Intas Gets CDSCO Panel Nod to Conduct Phase III Trial of Pertuzumab Biosimilar for Breast Cancer
New Delhi: 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.
Pertuzumab is an antineoplastic agent used in combination with other therapies for treating HER2-positive metastatic breast cancer. It is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). The molecule comprises two heavy chains and two light chains containing 448 and 214 amino acid residues, respectively.
HER2 is a tyrosine kinase receptor that plays a critical role in cell proliferation, differentiation, and survival. It becomes activated through dimerization with other HER family receptors (e.g., HER3) or through ligand binding, which triggers downstream signaling pathways including Ras/MAPK, PI3K/Akt, and JAK/STAT. Overexpression or gene amplification of HER2 occurs in around 20% of breast cancers and is associated with a poorer prognosis.
Pertuzumab inhibits the dimerization of HER2, thereby blocking downstream signaling pathways involved in tumor growth and survival. It also promotes antibody-dependent cell-mediated cytotoxicity.
Earlier, Medical Dialogues had reported that the company received approval to manufacture and market Pertuzumab Concentrate for Solution for Infusion 420 mg/14 mL vial for the treatment of HER2-positive metastatic breast cancer.
At the recent SEC (Oncology) meeting held on 21st May 2025, the expert panel reviewed the submitted Phase III protocol. Following detailed deliberation, the committee recommended granting permission to conduct the trial as per the proposed protocol.
