GSK gets CDSCO Panel nod to import, market anticancer drug Dostarlimab
New Delhi: Highlighting the unmet medical need in the country, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to pharma major GSK for the import and marketing of anticancer drug dostarlimab concentrate for solution for infusion 500 mg/10 ml with a waiver of the Phase III clinical trial in the country.
This approval is subject to the condition that the firm conduct a Phase IV clinical trial.
This came after the drug major GSK presented the proposal to import and market the drug Dostarlimab concentrate as a solution for infusion of 500 mg/10 ml with a local clinical trial waiver indicated as monotherapy for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability high (MSI-H) recurrent or advanced endometrial cancer (EC) that has progressed on or following prior treatment with a platinum-containing regimen.
In addition, the firm presented the results of various clinical trials conducted in other countries.
Dostarlimab is an anti-PD-1 monoclonal antibody used in the treatment of mismatch repair deficient endometrial cancers and solid tumors with no alternative treatment options.
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.
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 Haematology, the expert panel reviewed the drug major GSK's proposal to import and market the drug Dostarlimab concentrate for solution for infusion 500 mg/10 ml indicated as monotherapy for the treatment of adult patients 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 regimen with a local clinical trial waiver.
The committee noted that the drug is approved in around 40 countries, including the US, European Union, United Kingdom, Canada, Australia, Switzerland, etc.
The committee opined that the drug falls under the category of orphan drug and is indicated for the treatment of life threatening diseases, and there is an unmet medical need in the country.
After detailed deliberation, the committee recommended the grant of permission to import and market the drug with a waiver of Phase III clinical trials in the country, with the condition that the firm should conduct a Phase IV clinical trial.
Accordingly, the committee suggested the firm submit the Phase IV clinical trial protocol within 3 months of import and marketing permission being granted.
