Hetero Biopharma Gets CDSCO Panel Nod for Phase IV Trial of Denosumab Injection in Cancer Patients
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to Hetero Biopharma Limited to conduct a Phase IV multi-centric, post-marketing clinical trial of Denosumab Injection 120 mg/0.7 ml.
The decision was taken during the SEC meeting held on August 20, 2025, at CDSCO headquarters in New Delhi.
The firm presented its proposal for a Phase IV clinical trial titled “A Phase IV Multi-Centric, Post-Marketing Study Evaluating the Safety, Immunogenicity and Efficacy of the Marketed Formulation of Hetero-Denosumab in patients with Advanced Malignancies involving Bone or Giant Cell Tumour of Bone” (Protocol No. HCR/IV/DENOSOL/01/2025, Version 1.0 dated March 18, 2025).tr6
The committee carefully reviewed the protocol, which aims to assess safety, immunogenicity, and efficacy of the marketed formulation in patients with advanced malignancies involving bone or giant cell tumour of bone.
After detailed deliberation, the SEC recommended granting permission to conduct the Phase IV clinical trial as per the protocol presented by the firm.
Denosumab is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand), a key mediator in the formation, function, and survival of osteoclasts. By blocking RANKL, Denosumab reduces bone resorption and is commonly used to prevent skeletal-related events in patients with bone metastases and to treat giant cell tumour of bone. It is considered an important supportive therapy in oncology settings where bone integrity is compromised due to cancer progression.
The note from the meeting clarified that Dr Kaushal Kalra did not participate in the deliberation for this agenda item.
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