MedPath

Belantamab mafodotin

Generic Name
Belantamab mafodotin
Brand Names
BLENREP
Drug Type
Biotech
Chemical Formula
-
CAS Number
2050232-20-5
Unique Ingredient Identifier
DB1041CXDG
Background

Belantamab mafodotin, or GSK2857916, is an afucosylated monoclonal antibody that targets B cell maturation antigen conjugated to the microtubule disrupter monomethyl auristatin-F (MMAF).

Belantamab mafodotin was granted FDA accelerated approval on 5 August 2020 for the treatment of multiple myeloma; however, its manufacturer began the process for withdrawal of the US marketing authorization in November 2022. In the meantime, belantamab mafodotin will be available for patients in the Risk Evaluation and Mitigation Strategy (REMS) program who can enrol in a compassionate use program.

Indication

Belantamab mafodotin is indicated in the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

Associated Conditions
Relapsed/Refractory Multiple Myeloma (RRMM)
Associated Therapies
-

USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma

USFDA accepts Blenrep combinations for review in treating relapsed/refractory multiple myeloma, potentially transforming treatment options with manageable side effects.
indianpharmapost.com
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Blenrep shows overall survival benefit in DREAMM-7 phase III trial for relapsed/refractory

Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone (BorDex) significantly reduced the risk of death in the DREAMM-7 phase III trial for relapsed/refractory multiple myeloma compared to daratumumab plus BorDex, showing a statistically significant and clinically meaningful overall survival benefit.
pipelinereview.com
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Blenrep shows overall survival benefit in head-to-head DREAMM-7 phase III trial for ...

GSK announces positive results from DREAMM-7 trial showing Blenrep plus BorDex significantly reduces death risk in relapsed/refractory multiple myeloma compared to daratumumab plus BorDex, with full data to be presented at 2024 ASH Annual Meeting.

Positive Outcomes from Phase III Multiple Myeloma Treatment Trial

GSK's Phase III DREAMM-7 trial for Blenrep (belantamab mafodotin) with bortezomib and dexamethasone in relapsed or refractory multiple myeloma met its key secondary endpoint of overall survival, indicating a significant reduction in the risk of death compared to standard care. The company plans to initiate a Phase III study for newly diagnosed multiple myeloma patients not eligible for transplant by late 2024.
pharmabiz.com
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GSK announces positive results from head-to-head DREAMM-7 phase III trial of Blenrep in ...

GSK's DREAMM-7 trial showed belantamab mafodotin + BorDex significantly reduced death risk vs. daratumumab + BorDex in relapsed/refractory multiple myeloma, meeting OS secondary endpoint. Full results to be presented at ASH 2024.
bnnbloomberg.ca
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GSK’s Withdrawn Blood Cancer Drug Paves Path Back to Market

GSK's Blenrep, combined with BorDex, significantly reduces death risk in relapsed myeloma patients, marking a potential treatment shift. Despite a 2022 setback and market withdrawal, GSK's efforts and new trial results aim to revive Blenrep's approval, with potential peak sales over £3 billion if successful.

DREAMM-7 Trial Shows Blenrep Combo Significantly Improves Overall Survival in Relapsed/Refractory Multiple Myeloma Patients

Interim results from the Phase III DREAMM-7 trial show Blenrep combined with bortezomib and dexamethasone significantly improves overall survival in relapsed/refractory multiple myeloma patients compared to Darzalex plus bortezomib and dexamethasone. The findings highlight Blenrep's potential to extend lives and transform treatment strategies.
onclive.com
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Dr Dimopoulos on Efficacy Findings From the DREAMM-8 Trial in Multiple Myeloma

The DREAMM-8 trial compared belantamab mafodotin-blmf, pomalidomide, and dexamethasone (BPd) to pomalidomide, bortezomib, and dexamethasone (PVd) in multiple myeloma patients. BPd showed superior progression-free survival (PFS) not reached vs 12.7 months (HR, 0.52; 95% CI, 0.37-0.73; 2-sided P < .001), deeper responses, and higher complete response rates (40% vs 16%).
marketwatch.com
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Cancer Antibody Drug Conjugates Market, Drugs Approval, Price, Sales & Clinical Trials

Antibody drug conjugates (ADCs) are a transformative class in cancer treatment, with 16 approved products and sales exceeding $10B in 2023. The market is expected to surpass $50B by 2030, driven by over 500 ADCs in clinical trials. Key players include Enhertu, Kadcyla, and Padcev, with significant sales in breast and lung cancers. The US and China lead the market, supported by robust R&D and regulatory environments.
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