The outcome was not surprising, in light of a negative vote by an FDA expert panel last month, but an investigator in the study criticized the agency's approach as being based on a poor understanding of acute myeloid leukemia.
A company spokesperson said the company was working to address the agency's concerns about the drug, quizartinib, for FLT3-mutated acute myeloid leukemia.
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The hold had been placed in February following two deaths in the study, including one in a patient who experienced cytokine release syndrome. The company has amended the trial protocol to mandate monitoring and management of CRS.
The drug was approved for FLT3-mutated acute myeloid leukemia in November based on response rate data, but the latest results show improvement on the gold-standard measure of overall survival.
The drug offers greater convenience and efficacy than the old chemotherapy combination, but its high cost and first impressions among doctors may explain why Jazz had to lower its sales guidance.
The drug, combined with Celgene's Vidaza, Otsuka's Dacogen or low-dose cytarabine, showed strong response rates in elderly and unfit AML patients, historically a hard-to-treat population.
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The drug is the second FLT3 inhibitor to win approval, after Novartis' Rydapt in first-line disease. Daiichi Sankyo's quizartinib could present competition if it wins approval, but it would target a somewhat narrower population of FLT3-mutated patients.
The approval is the latest of several drugs approved for the disease, a form of blood cancer, since last year.
Following two small Phase 1 trials, Cornerstone Pharmaceuticals announced Thursday that it has secured FDA-backing for pivotal trials of its lead drug in AML and late-stage pancreatic cancer.
Three out of five clinical trials evaluating Seattle Genetics' investigational ADC vadastuximab have ground to a halt after six adverse events and four fatalities were reported. No such toxicity has been reported in trials involving newly-diagnosed patients.
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