GSK: Japan agrees to review Blenrep application
(CercleFinance.com) - GSK announced on Tuesday that the Japanese health authorities have agreed to review the license application for Blenrep, its antibody drug conjugate, in relapsed or refractory multiple myeloma.
The British biopharmaceutical group states that the Japanese Ministry of Health, Labor and Welfare (MHLW) - which had granted orphan drug status to the dossier - will now consider whether to market the product in combination with bortezomib and dexamethasone (BorDex) or pomalidomide and dexamethasone (PomDex).
GSK points out that over 7200 new cases of multiple myeloma are diagnosed each year.
Blenrep was approved in Europe and the UK this summer.
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