Astellas’ Xospata wins FDA nod in AML, with Daiichi competition looming

On an acute myeloid leukemia (AML) roll, the FDA has green-lighted Astellas’ Xospata, also known as gilteritinib. For Astellas, it marks the first step toward challenging Novartis’ Rydapt and likely just a slim head start against Daiichi Sankyo. Xospata’s nod makes it the first monotherapy approved for AML patients with either one of two forms of FLT3 mutation—either FLT3 internal tandem duplication (ITD) or tyrosine kinase domain (TKD)—who’ve relapsed or are resistant to standard chemotherapy. It is also the first blood cancer nod for Astellas in the U.S. Astellas is pricing the drug at the wholesale acquisition price of $22,500 for a 30-day course of treatment, “in line with other recently launched branded AML treatments,” and will make the drug available in the following week, a company spokesperson told FiercePharma.