New Products

FDA stamps fast OK on Astellas’ pioneering FLT3 AML drug gilteritinib, expanding on a record year for new approvals

Astellas has picked up boasting rights to gaining the first FDA approval of a FLT3 inhibitor for a specific group of FLT3 positive acute myeloid leukemia patients — which accounts for close to a third of the population.

Back in May the Japanese pharma reported that the agency had offered a snap 6-month review on its fast-track program for gilteritinib, something that’s become quite common in the oncology group.

That’s good news for the 30% or so of the 19,000 newly diagnosed AML cases each year that will be linked to the genetic mutation. The drug has been in a pivotal study where investigators have been studying it’s ability to cut relapses in the patient population.

The drug will be sold as Xospata, and Astellas set the wholesale price at $22,500 for 30 days, which would translate to $270,000 for a year of therapy — though payers negotiate down from that figure. In a statement, the company said that their interim analysis of the pivotal program tracked a median duration of response of 4.6 months.

Alexander Edward Perl

This OK delivers a “new, highly-effective, and well-tolerated treatment option to the clinic for a group of truly high-risk patients who, until today, had no specific therapies available beyond chemotherapy to treat their disease,” says Alexander Perl, an associate professor of Hematology-Oncology at the University of Pennsylvania. Perl has been leading the clinical trial program for this drug.

“Although we’re waiting for the final analysis of (the Phase III study) ADMIRAL, the available data with gilteritinib show fewer and milder side effects than typically is seen with traditional chemotherapy,” Perl added, noting that they also tracked a significantly higher rate of complete responses.

The approval marks the FDA’s 54th OK of the year as it goes deeper into record territory after passing the old record set in 1996.



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