FDA grants accelerated approval for Keytruda for lung cancer treatment

The U.S. Food and Drug Administration (FDA) granted accelerated approval on Friday for Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express a protein called PD-L1.

Keytruda, marled by Merck, works by targeting the cellular pathway known as PD-1/PD-L1, which are proteins found on the body’s immune cells and some cancer cells. Through blocking this pathway, Keytruda may help the body’s immune system fight the cancer cells.

The FDA gave Keytruda breakthrough therapy designation for this indication because through preliminary clinical evidence, Merck demonstrated that the drug may offer a substantial improvement over available therapies. The drug also received priority review status, which is granted to drugs that have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition. 

“Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine,” FDA Center for Drug Evaluation and Research Office of Hematology and Oncology Products Director Richard Pazdur said. “Today’s approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug.”

Lung cancer is the leading cause of cancer death in the U.S., with an estimated 221,200 new lung cancer diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. NSCLC is the most common type of lung cancer.