Submit Separate Toxicity Data on Indian Subject: CDSCO Panel Tells GSK on BelantamabMafodotin study

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.

Belantamab Mafodotin, the anti-BCMA antibody moiety selectively binds to BCMA on tumor cell surfaces. Upon internalization, the MMAF moiety binds to tubulin and inhibits its polymerization, which results in G2/M phase arrest and induces tumor cell apoptosis.

At the recent SEC meeting for Oncology and Hematology held on the 6th and 7th of December 2023, the expert panel reviewed the reviewed phase –I Clinical trial, protocol no. 209664.

After detailed deliberation, the committee stated,

"Considering the serious adverse events in the study data presented by the firm (phase-I & II), it should be further evaluated through detailed results of adverse events on the ongoing study for further cycle therapy."

In addition, the expert panel suggested, "GSK Pharma should present separately the toxicity profile of Indian subjects."

In line with the above, the committee opined that the proposal should be re-deliberated for further consideration.

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