Dai­ichi Sankyo faces FDA chal­lenges on miss­ing da­ta, cred­i­bil­i­ty and safe­ty con­cerns in hunt for 2 new drug OKs

When Dai­ichi Sankyo’s team takes the floor at to­mor­row’s sched­uled meet­ing of the FDA’s can­cer drug ex­perts, they can ex­pect some hard ques­tions from reg­u­la­tors about two new ap­provals they’re push­ing for in the on­col­o­gy are­na.

Picked up 8 years ago in the $805 mil­lion Plexxikon buy­out, pex­i­dar­tinib was in a Phase I dose es­ca­la­tion study at the time. Over the years, the ki­nase in­hibitor gained a break­through drug des­ig­na­tion on its way to a fil­ing ear­li­er this year for adult pa­tients with be­nign tu­mors known as symp­to­matic tenosyn­ovial gi­ant cell tu­mor.

Cur­rent­ly, these cas­es are usu­al­ly treat­ed through surgery. But surgery isn’t al­ways pos­si­ble.

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