Em­bold­ened by AS­CO da­ta, FDA etch­es speedy ap­proval path for Io­vance's cer­vi­cal can­cer ther­a­py

Io­vance’s promis­ing da­ta snap­shot de­tail­ing the po­ten­tial of its cer­vi­cal can­cer drug at AS­CO has con­vinced the FDA to ac­cel­er­ate its path to ap­proval.

On Tues­day, the drug de­vel­op­er said the US reg­u­la­tor has rec­om­mend­ed that an on­go­ing mid-stage study of its ex­per­i­men­tal ther­a­py may be suf­fi­cient to sup­port an ap­pli­ca­tion to mar­ket LN-145 in pa­tients with ad­vanced cer­vi­cal can­cer.

“This feed­back is en­cour­ag­ing. The abil­i­ty to use the cur­rent study, as well as the Break­through Ther­a­py des­ig­na­tion re­cent­ly grant­ed to LN-145, al­lows us to plan on a path to BLA sub­mis­sion in the sec­ond half of 2020,” Io­vance chief Maria Fardis said in a state­ment. The com­pa­ny’s shares climbed about 2.6% to $25.26 be­fore the bell.

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