Keytruda Approved By FDA to Treat Certain Advanced Lung Cancers

Keytruda Approved By FDA to Treat Certain Advanced Lung Cancers
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October 2, 2015

The Food and Drug Administration (FDA) has granted an accelerated approval for a new treatment option for individuals suffering from advanced non-small cell lung cancer (NSCLC).

The treatment called Keytruda (pembrolizumab) is designed to be used in tumors that express a protein called PD-L1. It is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.

Keytruda was approved under the agency's accelerated approval program, which allows the approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials.

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

Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body's immune cells and some cancer cells). By blocking this pathway, Keytruda may help the body's immune system fight the cancer cells.

In a 61-patient study to evaluate its effectiveness, tumors shrank in 41 percent of patients treated with Keytruda and the effect lasted between 2.1 and 9.1 months.

The safety of the treatment was studied in 550 patients with advanced NSCLC. The most common side effects of Keytruda included fatigue, decreased appetite, shortness of breath or impaired breathing (dyspnea) and cough.

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

Keytruda is marketed by Merck & Co.