GSK Gets CDSCO Panel Nod to study safety of anti-cancer drug Dostarlimab
New Delhi: Citing that the total number of evaluable patients in the study should be a minimum of 30, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to the drug major GSK Pharma for conducting the Phase IV clinical trial of the anti-cancer drug Dostarlimab concentrate for solution for injection50mg/mL.
This came after the drug major GSK presented the proposal to conduct a Phase IV clinical study titled “Phase 4, open label, non-comparative, interventional, multicenter study to evaluate the safety of dostarlimab in adult patients in India with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regime” vide Protocol No. 221460 dated 25.07.2023.
Dostarlimab is an anti-PD-1 monoclonal antibody used in the treatment of mismatch repair deficient endometrial cancers and solid tumours with no alternative treatment options.
Dostarlimab is an IgG4 humanized monoclonal antibody targeted against the human programmed death receptor-1 (PD-1). PD-1 receptors are found on T-cells and, when activated, serve to inhibit immune responses - some cancers leverage this system by overexpressing PD-1 ligands, thereby effectively inhibiting the anti-tumor immune response that would typically attempt to destroy the cancerous cells
In April 2021, dostarlimab was granted accelerated approval by the FDA - as GlaxoSmithKline's dostarlimab-gxly (Jemperli) - for the treatment of adult patients with recurrent or advanced mismatch repair deficient (dMMR) endometrial cancer experiencing disease progression despite treatment with platinum-containing chemotherapy regimens.
Dostarlimab is a monoclonal antibody targeted against PD-1 - it binds to the receptor and prevents interactions with PD-L1 and PD-L2, thus allowing the anti-tumor immune response to proceed unimpeded.
At the recent SEC meeting for Oncology and Hematology held on 7th and 8th December 2023, the expert panel reviewed a proposal to conduct a Phase IV clinical study of the anti-cancer drug Dostarlimab presented by GSK.
After detailed deliberation, the committee recommended the grant for conducting a Phase IV clinical study as per the presented protocol with the condition that the total number of evaluable patients in the study should be a minimum of 30.
Also Read: Roche Gets CDSCO Panel Nod to Study anti-cancer Drug Inavolisib
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