Keytruda (pembrolizumab) has been approved by the U.S. Food and Drug Administration to treat advanced cases of the most common type of lung malignancy, non-small cell lung cancer (NSCLC).
The drug is approved for people whose tumors produce a protein called PD-L1, and whose cancer has lingered despite use of other treatments, the agency said Friday in a news release.
Lung cancer is the most common cause of cancer death in the United States, accounting for more than 220,000 cases and more than 158,000 deaths so far this year, the FDA said.
Keytruda, in blocking the PD-L1 protein, helps the body better fight this cancer, the FDA explained. The drug was first approved in 2014 to treat advanced melanoma skin cancer.
Keytruda’s performance in fighting lung cancer was evaluated in clinical studies of 550 people with advanced disease. The most common side effects included fatigue, loss of appetite, impaired breathing and cough. Because the drug affects the immune system, less common side effects could include rash and blood vessel inflammation, the FDA said.
Pregnant women should not take Keytruda, which could harm a developing fetus, the agency warned.
In conjunction with Keytruda’s approval, the FDA said it approved a companion diagnostic to detect the PD-L1 expression among people with NSCLC.
Keytruda is marketed by Whitehouse Station, N.J.-based Merck & Co.