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BRIEF-Merck says FDA accepts two SBLAs for Keytruda
February 3, 2017 / 11:52 AM / 10 months ago

BRIEF-Merck says FDA accepts two SBLAs for Keytruda

Feb 3 (Reuters) - Merck & Co Inc

* FDA accepts two SBLAs for Merck’s Keytruda (pembrolizumab) for locally advanced or metastatic urothelial cancer in cisplatin-ineligible first-line and second-line post-platinum failure treatment settings

* Merck & Co Inc - PDUFA, or target action, date for both applications is June 14, 2017

* Merck & Co Inc - Keytruda also receives breakthrough therapy designation for second-line treatment based on Keynote-045 Source text for Eikon: Further company coverage:

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