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EU Accelerated Assessment Tracker

Will Novartis's Capmatinib Be Fast-Tracked Once It Is Filed?

 
• By Maureen Kenny

Novartis is trying its luck with capmatinib on the accelerated assessment front at the European Medicines Agency. Gilead and Astellas/Seagen have secured fast-track review for their respective potential new products while Sesen Bio and Amryt Pharma are dealing with rejection.

This tracker provides information on accelerated assessment requests for planned marketing authorization applications (MAAs) that have come before the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for a decision. It also tracks whether companies retain fast-track status for MAAs as they make their way through the EU centralized procedure.

The latest update – see table below – reflects developments from January, February, and March 2021. 

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