Green-lighted in Japan, FDA quickly spurns Daiichi Sankyo's flawed application for AML drug
Three days after winning Japanese approval for its acute myeloid leukemia drug quizartinib, Daiichi Sankyo is being forced to endure an embarrassing rejection at the hands of the FDA.
US regulators wasted no time in batting back quizartinib after first highlighting the messy data in its application in an internal review, that in turn persuaded a large majority of outside experts to recommend a rejection for the drug, which targets FLT3-ITD–positive AML cases.
Their application drew a stinging rebuke from FDA cancer czar Richard Pazdur, who said that the faulty application involved things he hadn’t seen in 20 years at the agency. Pazdur is well known for making a personal appearance at ODAC meetings when he wants to single out a company or a study for criticism.
Daiichi Sankyo bought this drug in their $410 million buyout of Ambit 5 years ago. Last August, the company scored a breakthrough therapy designation for it on the back of pivotal data that showed a 27% overall survival rate compared to 20% in the chemotherapy arm. But on closer inspection, the FDA concluded that Daiichi’s numbers were a reflection of a built-in bias.
The company kept it short in their statement Friday morning.
“Daiichi Sankyo is evaluating the Complete Response Letter and will determine next steps in the US,” said Antoine Yver, EVP and Global Head, Oncology Research and Development, Daiichi Sankyo.
Still on the line is a decision on pexidartinib, which won the panel vote despite serious concerns regarding liver toxicity. That drug, combined with a REMS program, stands a much better chance of approval.
Social image: Kristoffer Tipplaar, AP Images