Decision Time For MSD/AZ, Lilly, Kite EU Fast-Track Hopes
Three accelerated assessment requests will either be granted or rejected this week at the European Medicines Agency.
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KTE-X19, Kite’s potential new CAR-T therapy, will in the end be fast-tracked at the European Medicines Agency. Lilly failed to secure the speedy review it was seeking for selpercatinib
Priority review is likely in the US for Kite’s second CAR-T therapy offering but it seems the company will have to make do with standard review in the EU.