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The FDA has approved Daiichi Sankyo's (OTC:DSNKY) Vanflyta (quizartinib) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.
Daiichi Sankyo's approval puts the company in competition with Novartis AG's (NYSE:NVS) Rydapt (midostaurin) and Astellas Pharma Inc's (OTC:ALMPY) Xospata (gilteritinib).
Vanflyta is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation; improvement in overall survival with Vanflyta in this setting has not been demonstrated.
The FDA approval was based on the results of the QuANTUM-First trial published in The Lancet.
In QuANTUM-First, Vanflyta combined with standard cytarabine and anthracycline induction and standard cytarabine consolidation, and continued as maintenance monotherapy following consolidation, resulted in a 22% reduction in the risk of death compared to standard chemotherapy alone in patients with newly diagnosed FLT3-ITD positive AML.
While complete remission (CR) rates were similar between both arms of the trial, the median duration of CR was more than 2 three times longer at 38.6 months for patients receiving Vanflyta compared to 12.4 months for those receiving placebo plus standard chemotherapy alone.
The wholesale acquisition cost of the treatment is $546 per tablet for both the 17.7 mg and 26.5 mg dose, Reuters reported citing the company.
Astellas' oral tablet Xospata's wholesale acquisition cost is $22,500 for a month's supply, while the list price of Novartis' Rydapt is $7,495 for a 14-day treatment and $14,990 for a 28-day treatment.
