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Questions Surround Merck’s Withdrawal Of Keytruda Filing For Lung Cancer In EU

 
• By Ian Schofield

The withdrawal of Merck’s Keytruda NSCLC application in Europe suggests the firm filed too early, and it will now need to wait for the results of the Phase III KEYNOTE-189 study before submitting the drug again to the EMA.

Merck has withdrawn its Keytruda NSCLC application in the EU

Merck & Co. Inc.’s decision to pull its PD-1 inhibitor Keytruda (pembrolizumab) from the EU approval process for lung cancer has raised a few eyebrows, with some analysts saying the company was jumping the gun in seeking marketing authorization on the back of Phase II trial data. It will now have to wait until Phase III results are ready before filing again.

At least one analyst says he may have to revise his forecast for Keytruda sales growth, which was based partly on the expected EU approval of the drug in non-small

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