AstraZeneca gets CDSCO panel Nod to study anti-cancer drug Volrustomig in women with cervical cancer
New Delhi: The drug major AstraZeneca has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III clinical study of the anti-cancer drug Volrustomig in women with high-risk locally advanced cervical cancer (eVOLVE-Cervical).
This is a phase III, randomized, double-blind, placebo-controlled, multicenter, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIC to IVA cervical cancer with lymph node involvement) who have not progressed following platinum-based CCRT (Concurrent chemoradiotherapy).
This came after the drug major AstraZeneca presented Phase III clinical study protocol no. D7984C00002.
Volrustomig is under clinical development by AstraZeneca and is currently in Phase II for Gastric Cancer. Volrustomig, also known as MEDI5752 is a bispecific antibody developed by AstraZeneca, that targets programmed death 1 (PD-1) and cytotoxic T lymphocyte-associated antigen 4 (CTLA-4).
MEDI-5752 is under development for the treatment of solid tumors including metastatic non-small cell lung cancer, advanced renal cell carcinoma, metastatic gastric adenocarcinoma, hepatocellular carcinoma, biliary tract cancer, gastroesophageal border adenocarcinoma, undifferentiated pleomorphic sarcoma, myxofibrosarcoma, leiomyosarcoma, pleomorphic rhabdomyosarcoma, gallbladder cancer and pleomorphic liposarcoma.
The drug candidate is a bi-specific monoclonal antibody. It is administered through an intravenous route. It acts by targeting programmed cell death protein 1 (PD-1) and Cytotoxic T Lymphocyte Protein 4 (CTLA4). It is a new molecular entity
At the recent SEC meeting for oncology and hematology held on 29th and 30th November 2023, the expert panel reviewed the Phase III clinical study protocol of the anti-cancer drug Volrustomig (MEDI5752)/ Placebo Lyophilized powder for solution for infusion 250 mg/vial.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.
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