GSK's BCMA ADC Belantamab Mafodotin Designated for Breakthrough Therapy in China for Relapsed/Refractory Multiple Myeloma

Sep 03, 2024 09:57 CST Updated 09:57

GSK

Pharmaceutical R&D Manufacturer

On September 2, the CDE website showed that GlaxoSmithKline (GSK)Belantamab mafodotin proposed for inclusion in breakthrough therapy, forUnitedBortezomib and dexamethasone are used to treat adult patients with multiple myeloma who have received at least one prior therapy.

Belantamab mafodotin is a BCMA ADC developed by Seagen (which has been acquired by Pfizer). In December 2009, GSK andSeagen has reached an agreement to obtain the rights for research, development, production, and commercialization of the drug.

In 2020, Belantamab mafodotin (trade name:Blenrep）Approved for marketing in the United States and the European Union, forFor the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies (including anti-CD38 monoclonal antibodies, proteasome inhibitors, and immunomodulatory agents). However, due to confirmatory Phase IIIDREAMM-3 Study Fails to Meet Primary Endpoint，GSK withdrew the indication in the United States and the European Union in 2022 and 2023, respectively.

To ExploreThe Application Potential of Belantamab Mafodotin as a Second-Line Treatment for Multiple Myeloma Patients, GSKPreviouslyTwo Phase III studies were also conducted (DREAMM-7 andDREAMM-8). These two itemsThe study reached its primary endpoint in November 2023 and June 2024, respectively.

Currently, exceptBelantamab mafodotIn addition,Globally, only HDP-101 (Heidelberg Pharma/Huadong Medicine) A BCMA ADC is in clinical development.

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