Roche Gets CDSCO Nod To Study Anticancer FDC Drug
New Delhi: In a significant development, the drug major Roche has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Standard Control Organisation (CDSCO) to conduct Phase III clinical trial of anticancer combination drug, Atezolizumab Injection 1200mg/20ml Sorafenib 200 mg Lenvatinib.
However, this nod is subject to the condition that during screening visit Quantiferone-TB Gold test should be carried out and in subsequent visits, trial subjects should be further assessed for TB.
This came after Roche presented the proposal for the grant of permission to conduct a Phase III clinical trial with study protocol no. MO42541 version 3.0 dated 21 July 2022 before the committee.
Atezolizumab is a humanized monoclonal antibody immune checkpoint inhibitor that selectively binds to PD-L1 to stop the interaction between PD-1 and B7. 1 (ie, CD80 receptors). The antibody still allows interaction between PD-L2 and PD-1. Atezolizumab, as a single agent, is indicated in patients with locally advanced or metastatic urothelial carcinoma. Atezolizumab, as a single agent, is indicated in patients with metastatic NSCLC with high PD-L1 expression, regardless of histologic type.
Atezolizumab is a type of immunotherapy drug called an “immune checkpoint inhibitor”. It helps to stimulate the body's immune system to fight cancer. One way that cancer cells hide from the immune system is to take control of regulatory pathways like the "checkpoint" inhibitor pathway.
Sorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.
Sorafenib is indicated for the treatment of unresectable hepatocellular carcinoma and advanced renal cell carcinoma. In the US, it is also indicated for the treatment of patients with locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment.
Lenvatinib is a multiple receptor tyrosine kinase inhibitor that is FDA-approved and indicated for the treatment of radioactive iodine-refractory differentiated thyroid cancer (DTC), unresectable hepatocellular carcinoma (HCC), and advanced renal cell carcinoma (RCC).
At the recent SEC meeting for Oncology and Hematology held on 11th July 2023, the expert panel reviewed the proposal presented by Roche for the grant of permission to conduct a Phase III clinical trial with study protocol no. MO42541 version 3.0 dated 21 July 2022 before the committee.
After detailed deliberation, the committee recommended the grant of permission to conduct the study with the condition that during the screening visit, the Quantiferone-TB Gold test should be carried out and in subsequent visits trial subjects should be further assessed for TB.
