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BRIEF-U.S. FDA alerts about 2 clinical trials on hold evaluating Keytruda with multiple myeloma
August 31, 2017 / 3:18 PM / 25 days ago

BRIEF-U.S. FDA alerts about 2 clinical trials on hold evaluating Keytruda with multiple myeloma

Aug 31 (Reuters) - U.S. FDA

* U.S. FDA alerts healthcare professionals and oncology clinical investigators about two clinical trials on hold evaluating Keytruda in patients with multiple myeloma

* Says Merck was made aware of issue through external data monitoring committee recommendation and suspended the trials to enrollment on June 12, 2017‍​

* Says statement does not apply to patients taking Keytruda (pembrolizumab) for an approved indication​

* Says on July 3, 2017, the FDA required that all patients in these trials be discontinued from further investigation with the drug​

* Says will be working with sponsors of Keytruda, PD-1/PD-l1 cancer drugs, clinical investigators to determine extent of safety issue Further company coverage:

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