Abstract
The U.S. Food and Drug Administration (FDA) announced that it has granted priority review status for Merck’s anti-PD-1 drug Keytruda (pembrolizumab) for the treatment of small cell lung cancer (SCLC) as a monotherapy for patients whose disease has not responded to two or more lines of prior therapy.
“There is a significant need for new treatment options for small cell lung cancer, which has a five-year survival rate of only six percent overall,” said Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories, in a press release. “Keytruda has already been established as an important treatment option for many patients with advanced non-small cell lung cancer and this acceptance provides an opportunity to potentially benefit even more patients.”
Under the new supplemental Biologics License Application (sBLA) for the drug, Merck is seeking accelerated approval for this indication based on data from two of its ongoing clinical studies: the Phase II KEYNOTE-158 and Phase Ib KEYNOTE-028. The FDA has set a targeted action date of June 17, 2019. It is Merck’s first application for the use of Keytruda in SCLC.
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