Cel­gene's AML drug clears late-stage test

Cel­gene is gear­ing up for reg­u­la­to­ry sub­mis­sions af­ter a piv­otal acute myeloid leukemia (AML) study showed its drug helped pa­tients live longer.

The drug­mak­er — which is in the process of be­ing swal­lowed by Bris­tol-My­ers Squibb $BMY — test­ed its ex­per­i­men­tal drug, CC-486, in new­ly-di­ag­nosed pa­tients with AML who ful­ly or par­tial­ly ben­e­fit­ed from chemother­a­py.

In the 472-pa­tient QUAZAR AML-001 tri­al, pa­tients on sup­port­ive care were ei­ther giv­en CC-486 or a place­bo once dai­ly for two weeks. Main­te­nance treat­ment with CC-486 con­ferred a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in over­all sur­vival — meet­ing the main goal — as well as the end­point of re­lapse-free sur­vival, Cel­gene $CELG said on Fri­day.

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