The BTD was granted based on the interim results of the Phase III DREAMM-7 trial, which met its primary endpoint.
Japan's MHLW has accepted for review GSK's NDA for Blenrep for patients with relapsed or refractory multiple myeloma.
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 ...
A year after GSK pulled its BCMA-targeting antibody-drug conjugate (ADC) Blenrep from the US market as a later-line therapy for multiple myeloma, there are signs that the drug may still have a ...
Until recently, the pharmaceutical industry remained relatively insulated from the simmering trade war between China and the ...
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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 ...
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 ...
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 ...