Speedy EU Review For AZ/DS's Enhertu; Cheer Too For BMS/bluebird, Celgene And Rhythm
US And Japanese Approvals For Enhertu Are Already In The Bag
The European Medicines Agency has agreed to fast track the review of four marketing applications in recent months.The products include AstraZeneca's advanced breast cancer treatment, Enhertu, two investigational CAR-T therapies, and a potential treatment for rare genetic disorders of obesity.
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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.
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.
Potential treatments from BeiGene, AstraZeneca, Bayer and Cancer Prevention Pharmaceuticals are under review at the European Medicines Agency.