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
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statnews.com
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Johnson & Johnson seeks first drug approval for treatment of smoldering myeloma

Johnson & Johnson seeks approval for Darzalex to treat high-risk smoldering myeloma, with AQUILA trial showing reduced risk of disease progression. GSK's Blenrep, after withdrawal, shows improved survival in DREAMM-7 trial. Emerging efforts aim to ease conditioning for genetic treatments in sickle cell disease. Kura Oncology's menin inhibitor shows promising results in AML, facing competition from J&J and Syndax. Pfizer's Oxbryta withdrawal for sickle cell disease remains unexplained.
gsk.com
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Blenrep (belantamab mafodotin) combination accepted for priority review in China

NMPA accepted GSK's NDA for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone for relapsed or refractory multiple myeloma, based on DREAMM-7 trial results showing significant efficacy, including overall survival. This marks the seventh major regulatory filing acceptance for belantamab mafodotin combinations this year.
pharmexec.com
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FDA Accepts GSK's Biologics License Application of Blenrep for Relapsed or Refractory

The FDA accepted GSK's BLA for Blenrep in combination with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) for relapsed or refractory multiple myeloma, supported by Phase III DREAMM-7 and DREAMM-8 trials. Blenrep combinations showed clinically meaningful improvements in efficacy endpoints, with manageable side effects. The FDA action date is set for July 23, 2025.
medpagetoday.com
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Year in Review: Multiple Myeloma

Belantamab mafodotin's comeback, FDA approvals for subcutaneous daratumumab-hyaluronidase and expanded CAR T-cell products, and isatuximab-based quadruplet emerging as new standard for transplant-ineligible newly diagnosed multiple myeloma patients.
finance.yahoo.com
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GSK eyes up combo approval for previously withdrawn myeloma drug

GSK’s Blenrep, withdrawn in 2022, seeks FDA approval in combination with Velcade/dexamethasone or Pomalyst/dexamethasone for multiple myeloma patients with prior therapy. Based on DREAMM-7 and DREAMM-8 trials, Blenrep combos showed significant PFS improvements over standard-of-care, with manageable safety profiles. Expected to compete with BCMA CAR-T therapies like Carvykti and Tecvayli, Blenrep could offer simpler IV infusion benefits.
morningstar.co.uk
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GSK's Blenrep combinations accepted for review by US FDA

GSK's Blenrep combinations for relapsed and refractory multiple myeloma accepted by the US FDA, with a decision expected by July 23. The application covers Blenrep with BorDex and PomDex for patients who have undergone at least one prior therapy.

FDA Accepts Blenrep Combination For Review In Treatment Of Relapsed/Refractory

GSK's BLA for Blenrep in combinations with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) for multiple myeloma treatment accepted by FDA, with action date of 23 July 2025. Based on DREAMM-7 and DREAMM-8 trials, showing significant PFS improvements.
gsk.com
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Blenrep combinations accepted for review by the US FDA for the treatment of relapsed

GSK's Blenrep (belantamab mafodotin) combinations with BorDex (BVd) and PomDex (BPd) for multiple myeloma treatment, supported by DREAMM-7 and DREAMM-8 trials, submitted for FDA review with an action date of 23 July 2025. DREAMM-7 showed statistically significant overall survival benefits.
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