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Merck: FDA refuses six-week dosing application for Keytruda

(CercleFinance.com) - Merck said on Wednesday that the US Food and Drug Administration has refused to approve a new six-week dosing schedule for its blockbuster cancer drug Keytruda.


In a so-called "complete response letter" (CRL), the FDA rejected Merck's supplemental biologics license applications seeking to update the dosing frequency for its immunotherapy.

The US drugmaker wanted to include a 400 mg dose infused over 30 minutes every-six-weeks option in multiple indications.

Keytruda is typically administered as an intravenous infusion over 30 minutes every three weeks.

The six-week dosing schedule was supposed to provide physicians and patients with "greater flexibility" in their treatment plans.

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