Reliance Life Gets CDSCO Nod for Nivolumab Trial

CDSCO has given approval to Reliance Life Sciences Pvt. Ltd. for conducting a Phase I/III clinical trial of its biosimilar Nivolumab (R-TPR-067, RLS-Nivolumab). The approval is subsequent to the Subject Expert Committee (Oncology).

The title of the trial is "A Prospective, Multicenter, Randomized, Double-Blind, Parallel-Group, Two-Arm Comparative Phase I/III Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of RLS-Nivolumab and Opdivo /Opdyta in Patients Previously Treated for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)." The trial will examine the equivalence of the two drugs in patients with NSCLC that has progressed locally or metastasized.

Nivolumab is a PD-1 immune checkpoint inhibitor that revamps the body's immune system to identify and kill cancer cells. Nivolumab is approved worldwide for various cancers such as NSCLC, melanoma, renal cell carcinoma, and head and neck squamous cell carcinoma.

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The clinical trial is to demonstrate the equivalence of RLS-Nivolumab and the reference drugs in terms of efficacy, safety, pharmacokinetics, and immunogenicity. It is a huge step in providing access to high-end cancer drugs at a reasonable price to Indian patients and even globally.

Reliance Life Sciences, a member of the Reliance Group, is an Indian biotechnology leader, which is committed to the research, development, and production of complex biologics, biosimilars, and novel therapeutic entities with the concentration of oncology, immunology, and other life- threatening diseases.