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).
Mezigdomide is a modulator of the E3 ubiquitin ligase complex containing cereblon (CRL4-CRBN E3 ubiquitin ligase), with potential immunomodulating and antineoplastic activities. Upon administration, mezigdomide specifically binds to cereblon (CRBN), thereby affecting the ubiquitin E3 ligase activity, and targeting certain substrate proteins for ubiquitination. This induces proteasome-mediated degradation of certain transcription factors, some of which are transcriptional repressors in T-cells. This leads to modulation of the immune system, including activation of T-lymphocytes, and downregulation of the activity of other proteins, some of which play key roles in the proliferation of certain cancer cell types. CRBN, the substrate recognition component of the CRL4-CRBN E3 ubiquitin ligase complex, plays a key role in the ubiquitination of certain proteins.
At the recent SEC meeting for oncology, the expert panel reviewed phase 3 clinical study protocol no. CA057001 version 04 dated 10 May 2023.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.
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