FDA Rejects Keytruda Dosing, Fast Tracks Tecentriq Lung Cancer Review

Contrasts With EMA Decision

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...

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