The U.S. Food and Drug Administration on Friday approved Merck & Co Inc’s immunotherapy, Keytruda, for patients with advanced non-small cell lung cancer, the most common form of the disease.
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Keytruda (pembrolizumab) can be used to treat advanced non-small cell lung cancer in patients whose disease has progressed after previous treatments and who have tumors that express a protein called PD-L1, the agency said.
Both Keytruda and Opdivo work by blocking a substance on immune cells known as PD-1, disrupting its interaction with PD-L1 on cancer cells. The drug was first approved in 2014 to treat advanced melanoma skin cancer.
The immunotherapy was approved along with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test. Lung cancer is also by far the leading cause of cancer death in the U.S. About 85 percent to 90 percent of lung cancers are classified as non-small cell. “The durability of response with immune checkpoint inhibitors is exciting and has given new options for our patients”, Naiyer Rizvi, director of Thoracic Oncology and director of Immunotherapeutics, New York Presbyterian Hospital, Columbia University Medical Center, and a principal investigator for the Keytruda lung cancer clinical program. This lifts a natural brake on the immune system and allows it to kill cancer cells.
A test will let doctors examine the tumors for PD-L1 levels before treatment.
Merck said the price of Keytruda for health insurers and other payers is around $12,500 per month. The combination of Yervoy and Opdivo is expected to cost between $141,000 and $256,000, depending on length of treatment. Tumors shrank in 41 percent of those patients, an effect that lasted anywhere from two to nine months. Fatigue, decreased appetite, dyspnea, and cough were the most common side effects with Keytruda.
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“I think there’s going to be more and more interest on the part of oncologists in using PD-L1 expression in making decisions about how best to treat their lung-cancer patients”, Merck’s Dr. Perlmutter said.
