R-TPR-067 (nivolumab biosimilar) / Reliance Life Sci - LARVOL DELTA

The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has granted approval to Reliance Life Sciences Pvt. Ltd. to conduct a Phase I/III clinical trial for its biosimilar Nivolumab (R-TPR-067, RLS-Nivolumab). (Medical Dialogues) - "In light of the earlier recommendation of SEC (Oncology) dated March 20, 2025, the firm presented the protocol to conduct a Phase I/III clinical trial titled 'A Prospective, Multicenter, Randomized, Double-Blind, Parallel-Group, Two-Arm Comparative Phase I/III Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of R-TPR-067 (RLS-Nivolumab) and Opdivo/Opdyta administered by intravenous route in Patients previously treated for Locally Advanced or Metastatic Non-Small Cell Lung Cancer' vide Protocol No.: RLS/ONC/2024/05 Version 2.0 dated April 9, 2025."

New trial • Non Small Cell Lung Cancer