GSK gets CDSCO panel okay to conduct study on antineoplastic drug Belantamab Mafadotin
New Delhi: In a significant development, GSK Pharmaceuticals ( India) has got approval from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organization (CDSCO) to conduct the Phase 2a clinical trials for the antineoplastic agent Belantamab Mafodotin intravenous solution.
This nod came in line with the condition that the study sites must have an ophthalmologist as Co-Investigator or Sub-Investigator. Furthermore, the expert panel stated that in the event of an adverse event, the study participant(s) should be followed by the study eye doctor for the duration of the study or until the AE is resolved.
This came in the wake of the protocol presented by the drug major, GSK Pharmaceuticals, in the presence of an Ophthalmology expert, for the phase 2a clinical trials (DREAMM 14), study protocol no. 209628, version-01 dated 21st January 2022.
Belantamab Mafadotin is an antineoplastic agent used for the treatment of relapsed and refractory multiple myeloma. It works by slowing or stopping the growth of cancer cells. Belantamab Mafodotin is the latest advance in immunotherapy for multiple myeloma.
Multiple myeloma is a hematologic malignancy characterised by excessive clonal proliferation of plasma cells. The treatment of multiple myeloma presents a variety of unique challenges due to the complex molecular pathophysiology and incurable status of the disease at this time.
Belantamab Mafadotin is a humanised IgG1K monoclonal antibody against the B-cell maturation antigen (BCMA) conjugated with a cytotoxic agent, maleimidocaproyl monomethyl auristatin F (mm MMAF). The antibody-drug conjugate binds to BCMA on myeloma cell surfaces, causing cell cycle arrest and inducing antibody-dependent cellular cytotoxicity.
The medication is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior treatments including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
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Belantamab Mafadotinwas granted FDA approval on August 5, 2020.
At the 120th SEC meeting for Oncology and Haematology, held at CDSCO on March 9th, 2022, the committee thoroughly examined the study protocol presented by GSK Pharmaceuticals Ltd.
After detailed deliberation, the committee recommended the grant of permission to conduct the study with the following conditions:
1) The study sites must have Ophthalmologist as Co-Investigator or Sub-Investigator.
2) In case of an adverse event, the study participant(s) should be followed up to full length or till the resolution of AE by the study Ophthalmologist.
