Opdivo is approved by the FDA to treat melanoma as well as squamous non-small cell lung cancer, a smaller subset of the disease.
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Earlier this week the FDA approved a combination of Opdivo and another immune-targeting cancer drug called Yervoy to treat melanoma – a duo that could cost $250,000 a year.
The drug, called Keytruda, uses the body’s immune system to fight tumors. The results, published in May in the New England Journal of Medicine, found that 19.4 percent of all patients responded to the drug, compared with 45.2 percent whose tumor cells expressed a certain amount of the molecule. The results showed that pembrolizumab had an overall response rate of almost 20% among 495 previously treated and treatment-naive patients with advanced or metastatic NSCLC.
The most common side effects of Keytruda included fatigue, decreased appetite, shortness of breath or impaired breathing, and cough. So by blocking the interaction between PD-1 and PD-L1, Keytruda in effect enables the patient’s immune system to attack the cancer.
Lung cancer is the leading cause of cancer deaths worldwide; the American Lung Association estimates more than 158,000 people in the USA will die from the disease this year alone.
The Merck & Co. drug was approved for use with a companion diagnostic test that is the first created to detect PD-L1 expression in non-small cell lung tumors, the FDA said in the news release. The drug is intended for patients whose disease spread despite treatment with chemotherapy drugs or other therapies.
In the 550 study participants with advanced NSCLC, severe immune-mediated side effects occurred involving the lungs, colon and hormone-producing glands.
The response rate and duration of response for Keytruda were much greater than for drugs traditionally used to treat lung cancer.
Pregnant or breast-feeding women should not take the drug because it may harm the fetus or baby, the agency noted.
The FDA granted Keytruda breakthrough status in 2014, and it received priority review for this indication. The 22C3 pharmDx test measures how many tumor cells are expressing the PD-L1 protein in order to identify patients who would benefit from Keytruda. Survival benefit or disease-related symptom improvements in patients being treated with Keytruda have not yet been established.
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The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
