Seagen's Tukysa la­bel ex­pand­ed; ADARx gets $46M script for RNA tri­al

Seagen just scored an­oth­er ap­proval for one of its lead drugs.

Tukysa won ac­cel­er­at­ed ap­proval from the FDA on Thurs­day to be used in com­bi­na­tion with Roche’s Her­ceptin for pa­tients with a spe­cif­ic type of HER2-pos­i­tive col­orec­tal can­cer. This is the first FDA-ap­proved treat­ment in HER2-pos­i­tive metasta­t­ic col­orec­tal can­cer, Seagen said in a state­ment.

FDA, which had giv­en Tukysa (tu­ca­tinib) break­through ther­a­py des­ig­na­tion and pri­or­i­ty re­view in this in­di­ca­tion, said that it was ap­proved based on a read­out from a Phase II tri­al that saw a 38% over­all re­sponse rate in 84 pa­tients, with three com­plete re­spons­es and the me­di­an du­ra­tion of re­sponse be­ing 12.4 months.

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