New Delhi: The drug major Merck has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct a non-interventional study (NIS) of Avelumab concentrate for solution for infusion (Intravenous Infusion) in India.
This came after the drug maker Merck presented the proposal to conduct an interventional Study (NIS) on the Bavencio (Avelumab concentrate for solution for infusion (Intravenous Infusion) in India Vide Protocol No. MS100070_0133, version 2.0 dated 08 Nov 2022.
Avelumab is an anti-PD-L1 monoclonal antibody used to treat metastatic merkel cell carcinoma, metastatic urothelial carcinoma, or renal cell carcinoma. Avelumab is a human IgG1 lambda monoclonal antibody that binds programmed cell death ligand-1 (PD-L1) to block its interaction with its receptors found on T cells and antigen-presenting cells. PD-L1 blockade removes the suppression of T-cell activity, resulting in T-cell-mediated, adaptive antitumor immune responses.
At the recent SEC meeting for Oncology held on 7th and 8th February 2023, the expert panel reviewed the proposal to conduct an interventional Study (NIS) on the Bavencio (Avelumab concentrate for solution for infusion (Intravenous Infusion) in India vide protocol No. MS100070_0133, version 2.0 dated 08 Nov 2022.
After detailed deliberation, the committee recommended the firm conduct the study as per the presented protocol.
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