Review Of BMS's CAR-T Therapy Liso-Cel Gets Under Way At EMA
There Are Six Additions To The List Of Products Seeking EU Approval
Bristol Myers Squibb's lisocabtagene maraleucel, UCB's bimekizumab and Rhythm Pharmaceuticals' setmelanotide are among the six latest additions to the list of products under review at the European Medicines Agency.
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Two products that were under fast-track review at the European Medicines Agency have reverted to standard review timelines – Eiger's lonafarnib and GSK's dostarlimab. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.
Eiger attributes the change in status of the EU marketing authorization application for lonafarnib to the need for an inspection and the ongoing coronavirus pandemic.
As the first company with two approved chimeric antigen receptor T-cell therapies, Gilead’s Kite subsidiary has set a precedent by keeping the pricing the same as its first approved CAR-T, Yescarta.