FDA Announces Accelerated Approval of Keytruda

Keytruda treats patients with metastatic non-small cell lung cancer whose disease has progressed despite other treatment methods.

The FDA recently announced the accelerated approval for pembrolizumab (Keytruda) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose disease has progressed despite other treatment methods and with tumors that express a protein called PD-L1.

Keytruda is approved along with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test to detect PD-L1 expression in non-small cell lung tumors.

Safety and efficacy of Keytruda was tested in 550 patients with advanced NSCLC. Side effects included fatigue, decreased appetite, shortness of breath or impaired breathing, and cough. The drug also has the potential to cause more severe side effects that are a result of the immune system effect of Keytruda.