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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER