Justify dose modification criteria for anti-cancer drug: Authority tells GSK
New Delhi: In line with the drug major GSK's proposal to conduct a study of anti-cancer drug Belantamab mafodotin, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has sought justification for dose modification criteria as per protocol.
In addition, the committee has also sought justification for randomization of subjects in the proposed open label study to avoid study centre bias as the applicant has proposed 15 subjects from 13 sites in the country.
This came after the firm presented the proposed Phase II DREAMM-14 study protocol no. 209628; Version: 1.0; Date: 06-JAN-2022 before the committee.
Belantamab mafodotin is an antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via a non-cleavable linker.
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It is indicated in the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
On August 6, 2020, the FDA approved GSK's belantamab mafodotin-blmf for the treatment of patients with relapsed or refractory multiple myeloma.
At the latest SEC meeting for oncology and haematology, the committee thoroughly examined the proposed Phase II DREAMM-14 study protocol no. 209628; Version: 1.0; Date: 06-JAN-2022 before the committee.
After detailed deliberation, the committee opined that the firm should submit the following:
1. Justification for dose modification criteria as per protocol,
2. Justification for randomization of subjects in the proposed open-label study to avoid study centre-bias as the applicant has proposed 15 subjects from 13 sites in the country.
The committee also opined that the proposal should be further re-deliberated in the presence of an ophthalmology expert.
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