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FDA Action Alert: Wrapping up 2018 and Heading Into 2019

December 26, 2018 / Mark Terry

With the holidays upon us, along with the end of 2018 and the beginning of 2019, the U.S. Food and Drug Administration (FDA) squeezed some target action dates into the last weeks and beginning of the new year. As it turned out, these appear to be a mixed bag of extensions, resubmissions and supplemental applications, some of which are still pending while others have been approved earlier. Here’s a look. By now, everyone seemingly knows that Keytruda (pembrolizumab) is Merck & Company’s anti-PD-1 therapy, otherwise called a checkpoint inhibitor. There are more than 850 ongoing clinical trials using Keytruda in a broad range of cancers and treatment settings. As of October 22, the drug had been approved in 61 countries for second-line recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Merck had a target action date of December 28, 2018 for its supplemental Biologics License Application (sBLA) for Keytruda in previously treated patients with recurrent o...