FDA Approves Keytruda (Pembrolizumab) for Lung Cancer

The US Food and Drug Administration (FDA) has approved the immunotherapy drug Keytruda (pembrolizumab) to treat people with advanced non-small cell lung cancer that is getting worse, even after treatment with other drugs, and whose tumors have a protein called PD-L1. The approval includes a companion test to detect presence of the protein.

Keytruda is a type of anti-PD-1 drug. The PD-L1 protein on the surface of some cancer cells can help them avoid being found and destroyed by the body’s immune system. Drugs that block the PD-L1 protein, or the corresponding PD-1 protein on immune cells, can help the immune system recognize the cancer cells and attack them. The FDA first approved Keytruda in 2014 to treat some types of advanced melanoma skin cancer. Another anti-PD-1 drug, Opdivo (nivolumab) was approved by the FDA in March 2015 to treat a type of non-small cell lung cancer.

The FDA based its approval of Keytruda on a study of 61 people who were a subgroup of a much larger clinical trial. The 61 people had advanced non-small cell lung cancer, had been treated previously with other drugs, and had PD-L1-positive tumors, based on results of the new test. Tumors shrank in 41% of people treated with Keytruda, and the results lasted between 2.1 months and 9.1 months.

In addition, the safety of Keytruda was demonstrated in a study of 550 people with advanced non-small cell lung cancer. The most common side effects were fatigue, decreased appetite, trouble breathing, and cough. Keytruda also has the potential to cause the immune system to attack other parts of the body, which can lead to severe side effects. Women who are pregnant or breastfeeding should not take Keytruda.

Keytruda was approved to treat non-small cell lung cancer under the FDA’s accelerated approval program for drugs that show promise against a serious disease. The company that makes the drug must submit additional clinical information after approval, to demonstrate its benefit.

The drug also received priority review status, under which the FDA tries to make a decision within 6 months instead of the usual 10 months, and it received breakthrough therapy designation, for drugs that have the potential to offer a substantial improvement over existing therapies.

Keytruda is marketed by Merck & Co.

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