FDA Approves Keytruda® for Lung Cancer

Posted on October 13th, 2015 by

The programmed death (PD-1) inhibitor Keytruda® (pembrolizumab) has been granted approval by the US Food and Drug Administration (FDA) for use in lung cancer, becoming the first PD-1 inhibitor and the second immunotherapy available for treatment of this disease.

PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1, such as Keytruda, may enhance the ability of the immune system to fight cancer. In earlier studies Keytruda has demonstrated anticancer activity in lung cancer and has been previously approved for the treatment of advanced melanoma.

Keytruda was approved along with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, which is the first test designed to detect PD-L1 expression in lung cancers.

The FDA’s approval of Keytruda was based in part on data from the KEYNOTE-001 trial, which showed that Keytruda had an overall response rate of nearly 20% among 495 previously treated and treatment-naive patients with advanced or non-small cell lung cancer (NSCLC) and 45.2%, among individuals whose cancers expressed high levels of PD-L1.

The average overall survival was 9.3 months for previously treated patients, and over 16 months for previously untreated patients.

Overall Keytruda is well tolerated. The most common side effects of Keytruda included fatigue, anorexia, shortness of breath, and cough. Keytruda also has the potential to cause severe immune-mediated adverse effects. Breast-feeding or pregnant women should not take Keytruda because it may cause harm to the fetus or newborn baby, according to the FDA.

Source: FDA press release.


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Tags: General Lung Cancer, KEYNOTE-001 trial, keytruda, Lung Cancer, News, PD-1 inhibitor, PD-L1, pembrolizumab

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