FDA green­lights Ot­su­ka sub­sidiary's bile duct can­cer drug

Ot­su­ka sub­sidiary Tai­ho On­col­o­gy nabbed an ac­cel­er­at­ed ap­proval on Fri­day for Lyt­go­bi (futiba­tinib), its new ki­nase in­hibitor to treat adults with a type of pre­vi­ous­ly treat­ed bile duct can­cer, known as metasta­t­ic in­tra­hep­at­ic cholan­gio­car­ci­no­ma har­bor­ing fi­brob­last growth fac­tor re­cep­tor 2 (FGFR2) gene fu­sions or oth­er re­arrange­ments.

The ac­cel­er­at­ed ap­proval (mean­ing a con­fir­ma­to­ry tri­al is nec­es­sary to show clin­i­cal ben­e­fit) fol­lows a short­ened six-month re­view, thanks to the FDA’s Re­al-Time On­col­o­gy Re­view pro­gram.

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