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Decision Time For MSD/AZ, Lilly, Kite EU Fast-Track Hopes

Executive Summary

Three accelerated assessment requests will either be granted or rejected this week at the European Medicines Agency.

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EU Speedy Review Success For Kite But Not For Lilly

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

Fast-Track Fail For Kite’s KTE-X19 EU Review?

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. 

EU Accelerated Assessment Tracker

The European Medicines Agency this year is known to have granted ten requests for accelerated assessment of planned EU marketing authorization applications. Nine such requests are known to have been rejected. As 2019 draws to a close, the outcomes of five requests are still unknown.

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