No­var­tis lands cap­ma­tinib ap­proval, giv­ing them a sec­ond po­ten­tial block­buster from In­cyte

Over a decade af­ter No­var­tis promised In­cyte up-to $1.1 bil­lion for a pair of ear­ly stage drugs, the sec­ond of the two has crossed the fin­ish line.

The FDA has grant­ed ac­cel­er­at­ed ap­proval to cap­ma­tinib, a pill for non-small cell lung can­cers with a ME­Tex14 mu­ta­tion. The drug, now brand­ed as Tabrec­ta, is the first drug ap­proved to tar­get pa­tients with that mu­ta­tion, which now joins ALK, RET, ROS and EGFR on the list of non-small lung can­cers that can be treat­ed with tar­get­ed ther­a­pies. No­var­tis es­ti­mates around 4,000 to 5,000 pa­tients are di­ag­nosed with ME­Tex14 pos­i­tive NSCLC each year, or around 3% to 4% of all NSCLC pa­tients.

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