CDSCO Panel Approves Roche's Protocol Amendment Proposal For Anti-cancer Drug Atezolizumab, Lenvatinib, and Sorafenib Study

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Roche's proposal for the protocol amendment of the Clinical trial titled "A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab".

This came after the firm presented protocol amendment version 4 dated 09 November 2022 and protocol amendment version 5 dated 31 March 2023 protocol no. MO42541. This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.

Atezolizumab injection is used alone to help prevent non-small cell lung cancer (NSCLC) from coming back in patients whose tumor has been removed by surgery and who have received other cancer medicines (eg, platinum). It is given to patients who have stage 2 to stage 3A NSCLC and whose tumors express PD-L1.

Lenvatinib is FDA-approved for the treatment of radioactive iodine-refractory differentiated thyroid cancer (DTC), unresectable or advanced hepatocellular carcinoma (HCC), and advanced renal cell carcinoma (RCC). It is a multiple receptor tyrosine kinase inhibitor that demonstrates potent antiangiogenic properties.

Sorafenib is used to treat late-stage kidney cancer (advanced renal cell carcinoma), liver cancer (hepatocellular carcinoma) that cannot be treated by surgery, and differentiated thyroid cancer that has come back or spread to other parts of your body. Sorafenib is an antineoplastic (cancer) agent.

At the recent SEC meeting for Oncology on 5th March 2024, the expert panel reviewed the proposal amendment version 4 dated 09 November 2022, and protocol amendment version 5 dated 31 March 2023 protocol no. MO42541 .

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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