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Fast AZ Tagrisso Approval Springboard For Clovis?

 
• By Donna Young

Prescription Drug User Fee Act (PDUFA) action dates have become meaningless at the FDA's Office of Hematology and Oncology Products, which has almost consistently for the past year or two leaped ahead of those timelines and approved cancer medicines well ahead of schedule – the most recent being AstraZeneca PLC's lung cancer drug Tagrisso (osimertinib).

Prescription Drug User Fee Act (PDUFA) action dates have become meaningless at the FDA's Office of Hematology and Oncology Products, which has almost consistently for the past year or two leaped ahead of those timelines and approved cancer medicines well ahead of schedule – the most recent being AstraZeneca PLC's lung cancer drug Tagrisso (osimertinib).

The FDA wasn't due to act on the Tagrisso application until Feb. 6, 2016, but gave its nod to the...

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