FDA hands Bris­tol My­ers a land­mark ap­proval in ear­ly-stage lung can­cer af­ter just five days

On Feb. 28, the FDA ac­cept­ed Bris­tol My­ers Squibb’s ap­pli­ca­tion for ap­proval of a new use of block­buster check­point in­hibitor Op­di­vo and said it would make a de­ci­sion by Ju­ly 13.

That es­ti­mate turned out to be con­ser­v­a­tive, to say the least. On Fri­day, just five days af­ter ac­cept­ing the ap­pli­ca­tion, the FDA OK’d it, hand­ing the Big Phar­ma a land­mark ap­proval.

Op­di­vo can now be used to treat pa­tients with ear­ly-stage non-small cell lung can­cer pri­or to re­ceiv­ing surgery to re­move their tu­mor. Al­though Op­di­vo and oth­er PD-(L)1 in­hibitors have al­ready trans­formed treat­ment for more ad­vanced forms of the dis­ease, im­prov­ing sur­vival by re­plac­ing or sup­ple­ment­ing tox­ic chemother­a­py with more tol­er­a­ble and ef­fec­tive mol­e­cules that take the “brakes” off the im­mune sys­tem, the drugs have yet to reach many of the ear­li­est stage pa­tients.

Endpoints News

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.