Fol­low­ing PhI­II break­down, As­traZeneca cruis­es to­ward an FDA de­ci­sion for its BTK block­buster hope­ful acal­abru­ti­nib

Just when As­traZeneca would pre­fer to turn away from its Phase III break­down with dur­val­um­ab and treme­li­mum­ab, along comes acal­abru­ti­nib.

Yes­ter­day, their BTK in­hibitor was grant­ed a break­through ther­a­py des­ig­na­tion at the FDA, and reg­u­la­tors im­me­di­ate­ly backed it up to­day with a pri­or­i­ty re­view des­ig­na­tion that will speed up the over­sight process and quite like­ly of­fer an­oth­er can­cer drug ap­proval some­time in Jan­u­ary 2018.

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