Knives out at ODAC with vote against ac­cel­er­at­ed ap­proval for Spec­trum lung can­cer drug

Fol­low­ing the re­lease of scathing brief­ing doc­u­ments ear­li­er this week, FDA re­view­ers con­tin­ued to lam­bast Spec­trum Phar­ma­ceu­ti­cals’ po­ten­tial lung can­cer drug pozi­o­tinib, and out­side ad­vi­sors on ODAC vot­ed 9-4 against its ben­e­fit-risk pro­file.

FDA pre­sen­ters made clear on Thurs­day that there are ma­jor is­sues with the pozi­o­tinib ap­pli­ca­tion, in­clud­ing its ef­fi­ca­cy in the piv­otal tri­al, not be­ing an im­prove­ment over cur­rent­ly avail­able ther­a­pies (a re­quire­ment for an AA), the high rate of tox­i­c­i­ty, in­ad­e­quate dose op­ti­miza­tion (a prob­lem ini­tial­ly raised by FDA in 2017), and the de­layed con­fir­ma­tion of ben­e­fit con­sid­er­ing the com­pa­ny has yet to en­roll any pa­tients in its pro­posed con­fir­ma­to­ry study.

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