Bristol Myers Squibb India Gets CDSCO Panel Nod to Study anticancer drug Mezigdomide
New Delhi: The drug major Bristol-Myers Squib has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase III clinical trial of the anti-cancer drug Mezigdomide.
This came after the firm presented phase 3 clinical study protocol no. CA057001 version 04 dated 10 May 2023. This is a phase 3, two-stage, randomized, multicenter, open-label study comparing Mezigdomide (CC-92480), Bortezomib, and Dexamethasone (MEZIVd) versus Pomalidomide, Bortezomib, and Dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM): SUCCESSOR-1.
The purpose of this study is to compare the efficacy and safety of mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in participants with relapsed or refractory multiple myeloma (RRMM) who received between 1 to 3 prior lines of therapy and who have had prior lenalidomide exposure.
Mezigomide is an oral cereblon E3 ligase modulator (CELMoD) that is under clinical investigation in patients with relapsed/refractory (RR) multiple myeloma (MM).
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