Pfiz­er short­ens come­back cam­paign for armed an­ti­body in­o­tuzum­ab, lands quick FDA re­view

Pfiz­er’s armed an­ti­body in­o­tuzum­ab ozogam­icin — held up as a top on­col­o­gy con­tender at the phar­ma gi­ant — is be­ing giv­en the red car­pet treat­ment at the FDA. Pfiz­er said this morn­ing that reg­u­la­tors agreed to pro­vide a pri­or­i­ty re­view for the drug as a new treat­ment for re­lapsed or re­frac­to­ry B-cell pre­cur­sor acute lym­phoblas­tic leukemia.

The news marks the lat­est come­back ad­vance for the an­ti­body-drug con­ju­gate, which flopped in a Phase III tri­al for non-Hodgkin’s lym­phoma four years ago, bad­ly tar­nish­ing the prospects for a drug that had been tout­ed as a top con­tender by CEO Ian Read. In the fall of 2015, though, reg­u­la­tors hand­ed the com­pa­ny a break­through ther­a­py des­ig­na­tion for in­o­tuzum­ab, a few months af­ter Pfiz­er scored pos­i­tive late-stage da­ta in ALL.

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