No­var­tis scores a quick FDA OK for its new can­cer drug Lu­tathera, picked up in $4B buy­out

It didn’t take long for No­var­tis’ $NVS $4 bil­lion ac­qui­si­tion of Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions to pay off. The FDA has pro­vid­ed its stamp of ap­proval for their drug Lu­tathera, which us­es ra­dioiso­topes to tar­get cer­tain neu­roen­docrine tu­mors.

The piv­otal da­ta for the drug — used to treat gas­troen­teropan­cre­at­ic neu­roen­docrine tu­mors that af­fect the pan­creas or gas­troin­testi­nal tract — from the NET­TER-1 study demon­strat­ed a 79% re­duc­tion in the risk of dis­ease pro­gres­sion, with an in­ter­im me­di­an pro­gres­sion-free sur­vival rate of 8.4 months that had yet to max out. The FDA had ini­tial­ly bat­ted back the ap­pli­ca­tion on Lu­tathera at the end of 2016, ask­ing for some ad­di­tion­al work on the da­ta, which de­layed the ap­proval.

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