Zydus Life science’s anticancer drug Pertuzumab Gets CDSCO Panel Nod for Additional Indication of Early breast cancer

This came after Zydus Life Sciences presented the proposal for approval of additional indications of early breast cancer for the approved similar biologic Pertuzumab 30 mg/mL concentrate solution for infusion (rDNA origin) by way of extrapolation with a waiver of a local clinical trial.

Pertuzumab is an antineoplastic agent used in the treatment of HER2-positive metastatic breast cancer in combination with other antineoplastic agents.

Pertuzumab is a recombinant humanized monoclonal antibody that targets the extracellular dimerization domain (subdomain II) of the human epidermal growth factor receptor 2 protein (HER2). It consists of two heavy chains and two light chains that have 448 and 214 residues, respectively.

Human epidermal growth factor receptor-2 (HER2) is a tyrosine kinase receptor that plays an integral role in cell proliferation, differentiation, and survival. HER2 becomes active following dimerization with another HER2 receptor, another member of the HER protein family (e.g., HER3), or with a ligand; this dimer then phosphorylates and activates numerous intracellular signaling proteins, initiating signal transduction via pathways that include the Ras/mitogen-activated protein kinase pathway, the phosphatidylinositol 3′ kinase (PI3K)/Akt pathway, and then the Janus kinases/signal transducer and activator transcription pathway. HER2 is also a known oncogene; it is overexpressed or gene-amplified (i.e., HER2-positive) in approximately 20% of breast cancers, and these cancers carry a generally poorer prognosis than HER2-negative breast cancers.

Pertuzumab targets the extracellular dimerization domain (subdomain II) of HER2, thereby inhibiting ligand-initiated intracellular signaling via the MAP kinase and PI3K pathways. Inhibition of these pathways results in inhibition of cell growth and the initiation of apoptosis, respectively. Pertuzumab also appears to mediate antibody-dependent cell-mediated cytotoxicity.

At the recent SEC meeting for oncology held on June 5 and 6, 2024, the expert panel reviewed the proposal for approval of additional indications of early breast cancer for the approved similar biologic Pertuzumab 30 mg/mL concentrate solution for infusion (rDNA origin) by way of extrapolation with a waiver of a local clinical trial.

After detailed deliberation, the committee recommended the approval of an additional indication by way of extrapolation with a local clinical trial waiver, with the condition of conducting a Phase IV study in the proposed indication.

Accordingly, the expert panel suggested to the firm that the protocol to conduct the Phase IV study be submitted to CDSCO within three months of the grant of permission for the proposed additional indication.