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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER