GSK gets CDSCO Panel Nod To study Anti-cancer Drug Belantamab mafodotin
New Delhi: The drug major GSK has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase I clinical trial of the anti-cancer drug Belantamab mafodotin for injection 100 mg.
This approval, however, is conditional on CDSCO receiving the quarterly adverse event data.
This came after the drug major GSK presented results of adverse events on the ongoing study and toxicity profile of Indian subjects, protocol No. 209664.
Belantamab mafodotin is an anti-B-cell maturation antigen-antibody conjugated to a microtubule inhibitor to treat relapsed or refractory multiple myeloma. It is a first-in-class monoclonal antibody-drug conjugate (ADC) that has been developed for the treatment of multiple myeloma by GlaxoSmithKline.
Belantamab mafodotin is indicated in the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
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