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.
Belantamab mafodotin is an afucosylated monoclonal antibody that targets B cell maturation antigen (BCMA) conjugated to the microtubule distrupter monomethyl auristatin-F (MMAF). Afucosylation of the Fc region of monoclonal antibodies enhances binding to the Fc region, which enhances antibody-dependent cell-mediated cytotoxicity.
BCMA is uniquely expressed in CD138-positive myeloma cells. Targeting BCMA allows belantamab mafodotin to be highly selective in its delivery of MMAF to multiple myeloma cells. Belantamab mafodotin binds to BCMA, is internalised into cells, and releases MMAF.
The MMAF payload binds to tubulin, stopping the cell cycle at the DNA damage checkpoint between the G2 and M phases, resulting in apoptosis.
At the recent SEC meeting for Oncology held on 7th and 8th February 2023, the expert panel reviewed the adverse events on the ongoing study and toxicity profile of Indian subjects.
After detailed deliberation, the committee recommended the grant of permission to conduct the Phase I clinical trial with the condition that quarterly data of adverse events shall be submitted to CDSCO.
