GSK has asked the European Medicines Agency to fast track its planned EU marketing application for belantamab mafodotin, the company’s multiple myeloma treatment that was approved in the EU and the US as Blenrep but then withdrawn from both markets following a confirmatory study failure.
DREAMM Comeback Prompts GSK To Seek Fast-Track EMA Review For Blenrep
The European Medicines Agency is this week deciding whether the planned EU filings for sipavibart, lifileucel and Blenrep – which was previously approved but withdrawn in the EU and the US – merit an accelerated assessment.
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