The Cancer Letter

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Drugs & Targets

FDA extends Keytruda PDUFA date for microsatellite instability-high cancer

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FDA extended the action date for the supplemental Biologics License Application for Keytruda (pembrolizumab) for previously treated patients with advanced microsatellite instability-high cancer.

The drug is sponsored by Merck & Co. Inc. The company recently submitted additional data and analyses to the FDA related to the pending application. The submission of additional data is considered a major amendment to the sBLA under the Prescription Drug User Fee Act (PDUFA), thus extending the target action date by three months.

The new FDA target action date is June 9.

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