Submit Separate Toxicity Data on Indian Subject: CDSCO Panel Tells GSK on BelantamabMafodotin study
New Delhi: Considering the serious adverse events in the study data (phase-I & II) of Belantamab Mafodotin (GSK2857916) for Injection 100mg presented by drug major GSK Pharma, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that the firm should present separately the toxicity profile of Indian subjects.
This came after the drug major GSK Pharma presented the phase –I Clinical trial, protocol no. 209664.
The above study is a phase 3, randomized, open-label study of Belantamab Mafodotin administered in combination with Bortezomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone alone in participants with newly diagnosed multiple myeloma who are Ineligible for Autologous Stem Cell Transplantation.
Belantamab mafodotin is a medication for the treatment of relapsed and refractory multiple myeloma. The most common adverse reactions include keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue.
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