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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