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FDA Rejects Keytruda Dosing, Fast Tracks Tecentriq Lung Cancer Review

Contrasts With EMA Decision

 
• By Andrew McConaghie

Keytruda is set to remain dominant despite knockback, though Tecentriq could claim prized NSCLC adjuvant approval first

Merck

Merck & Co. Inc. has had its submission for a more convenient six-week dosing of its blockbuster immunotherapy treatment Keytruda refused by the US Food and Drug Administration.

The regulator has issued a complete response letter (CRL) to the company, which is seeking to introduce the every-six-weeks administration of a 400mg dose over 30 mins across multiple indications.

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