FDA adds fresh ‘break­through’ for No­var­tis' can­cer com­bo Tafin­lar and Mekin­ist

Just four months af­ter adding an FDA OK to sell its com­bo of Tafin­lar and Mekin­ist for non-small cell lung can­cer with a BRAF V600E mu­ta­tion, No­var­tis says that US reg­u­la­tors have hand­ed them an­oth­er break­through ther­a­py des­ig­na­tion on stage III melanoma.

The BRAF/MEK com­bi­na­tion — bagged in their big as­set swap with Glax­o­SmithK­line — should now get VIP treat­ment for stage III melanoma cas­es in­volv­ing this par­tic­u­lar mu­ta­tion af­ter in­ves­ti­ga­tors post­ed a 53% re­duc­tion in the risk of death or re­cur­rence in Phase III com­pared to place­bo last month.

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