The BTD was granted based on the interim results of the Phase III DREAMM-7 trial, which met its primary endpoint.

Drug maker GSK plc (GSK, GSK.L) announced Tuesday that Blenrep (belantamab mafodotin) combinations in relapsed/refractory multiple ...

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 ...

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 ...

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 ...

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GSK’s Blenrep in combo with BorDex receives China NMPA breakthrough therapy designation to treat relapsed/refractory multiple myeloma: London, UK Saturday, September 14, 2024, 0 ...

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 ...

GSK plc (GSK, GSK.L) said that the Center for Drug Evaluation (CDE) of the National Medical Products Administration or NMPA in China ...

Japan’s MHLW accepts for review GSK’s NDA for Blenrep combinations in relapsed/refractory multiple myeloma: London, UK Wednesday, September 18, 2024, 10:00 Hrs [IST] GSK plc a ...

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 ...

China’s National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) for GSK's Blenrep (belantamab mafodotin ...