Pfiz­er wins a “break­through” ti­tle for ALK/ROS1 con­tender lor­la­tinib af­ter hus­tling in­to PhI­II

Last June at AS­CO, Pfiz­er re­searchers were hap­py to dis­cuss the pos­i­tive hu­man da­ta they had plumbed for lor­la­tinib (PF-06463922), their “next-gen­er­a­tion” ALK/ROS1 ty­ro­sine ki­nase in­hibitor. Hus­tling it in­to Phase II, Pfiz­er saw this pro­gram as a key part of its on­col­o­gy sto­ry, which has played a ma­jor role in win­ning new re­spect for the phar­ma gi­ant’s pipeline ef­forts.

Now the FDA is en­dors­ing that sen­ti­ment, giv­ing Pfiz­er its break­through drug des­ig­na­tion for this drug — now in a piv­otal tri­al — which could help fur­ther ac­cel­er­ate it along the path­way to a po­ten­tial ap­proval.

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