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 ...

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 ...

Until recently, the pharmaceutical industry remained relatively insulated from the simmering trade war between China and the ...

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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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 ...

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 ...