FDA Action Alert: Wrapping up 2018 and Heading Into 2019

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 or metastatic head and neck squamous cell carcinoma. The application was based on data from the Phase III KEYNOTE-040 clinical trial. However, on October 22, the company released significantly improved overall survival data for Keytruda from its Phase III KEYNOTE-048 trial. The company stated at that point, with the data so good, it planned to file an sBLA for Keytruda for a first-line indication based on the KEYNOTE-048 data that will include data from KEYNOTE-040 as supportive data. “Based on these results,” the company stated, “Merck has withdrawn the sBLA for KEYNOTE-040 for KEYTRUDA as a second-line treatment in patients with recurrent or metastatic HNCSC, which was previously assigned a Prescription Drug User Fee Act (PDUFA) or target action date of Dec. 28, 2018.”