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DREAMM Comeback Prompts GSK To Seek Fast-Track EMA Review For Blenrep

 
• By Neena Brizmohun

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week deciding whether the planned EU filings for sipavibart, lifileucel and Blenrep – which was previously approved but withdrawn in the EU and the US – merit an accelerated assessment.

fast capsule
The EMA is considering requests to speed up its reviews for three treatments • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock image

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mafodotin, the company’s multiple myeloma treatment that was approved in the EU and the US as Blenrep but then withdrawn from both markets following a confirmatory study failure.

The move follows positive results from two Phase III trials that evaluated the drug in multiple myeloma treatment settings different...

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