Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.
While Blenrep has been granted accelerated approval by the FDA for multiple myeloma patients who have received at least four prior therapies – including an anti-CD38 monoclonal antibody, a ...
The trial evaluated Blenrep (belantamab mafodotin), in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, bortezomib plus PomDex. A pre-specified interim ...
Blenrep, which is predicted by analysts to produce revenues of around $1.5bn in 2026, is an antibody-drug conjugate that works by targeting B-cell maturation antigen (BCMA), a protein commonly ...
Drug maker GSK plc (GSK, GSK.L) announced Tuesday that Blenrep (belantamab mafodotin) combinations in relapsed/refractory multiple ...
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of the National Medical Products Administration or NMPA in China has granted Breakthrough Therapy Designation to Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone or ...
MHLW also has granted orphan drug designation for Blenrep, which reflects the high unmet medical need and ensures priority NDA review in multiple myeloma. This is the third major regulatory filing ...
China’s NMPA granted BTD for Blenrep (belantamab mafodotin) combined with BorDex for the treatment of multiple myeloma.
GSK plc (GSK, GSK.L) said that the Center for Drug Evaluation (CDE) of the National Medical Products Administration or NMPA in China ...