A new JAK in­hibitor earns FDA nod in myelofi­bro­sis, set­ting up a fight with In­cyte, Bris­tol My­ers

The FDA on Tues­day hand­ed down an ac­cel­er­at­ed ap­proval for CTI Bio­Phar­ma’s JAK in­hibitor Von­jo (pa­cri­tinib) to treat in­ter­me­di­ate or high-risk pri­ma­ry or sec­ondary myelofi­bro­sis with a platelet count be­low 50 × 109/L, the com­pa­ny said in a re­lease.

Von­jo, which tar­gets JAK2 and IRAK1 with­out hit­ting the dread­ed JAK1 path­way, was ap­proved based on da­ta from the Phase III PER­SIST-2 study in which 29% of tar­get­ed myelofi­bro­sis pa­tients saw a re­duc­tion in spleen vol­ume of at least 35% com­pared with 3% on best avail­able ther­a­py, CTI said.

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