FDA approves Merck’s Keytruda for before and after lung cancer surgery

Mer­ck’s megablock­buster can­cer drug Keytru­da (pem­brolizum­ab) won a high­ly sought-af­ter FDA ap­proval as the first check­point in­hibitor to treat pa­tients with ear­ly-stage non-small cell lung can­cer (NSCLC) ei­ther be­fore or af­ter surgery.

The ap­proval, an­nounced Mon­day evening, is based on the re­sults of a Phase III study, known as KEYNOTE-671, that en­rolled about 800 peo­ple in the ear­ly stages of NSCLC. Every­one in the tri­al re­ceived chemo be­fore surgery, and half al­so got Keytru­da be­fore and af­ter. At two years, 62.4% of those who got Keytru­da kept their can­cer at bay, com­pared to 40.6% who got a place­bo.

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