52. Xospata


Active ingredient: gilteritinib
Disease: acute myeloid leukemia
Peak sales estimate: N/A
Approved: Nov. 28
Company: Astellas

The scoop: Astellas has landed on the blood cancer scene in the U.S. Its Xospata won an FDA nod to treat relapsed or refractory acute myeloid leukemia (AML) patients with a FLT3 mutation. The two mutation versions—ITD and TKD—represent about 30% of AML patients, and they’re associated with poor disease prognosis. Daiichi Sankyo’s FLT3 inhibitor competitor, quizartinib, is not far behind, having won an FDA priority review in FLT3-ITD with a decision date of May 25. As Xospata and potentially quizartinib square off in the second-line setting, they’re both eyeing newly diagnosed patients—a market currently dominated by Novartis’ Rydapt. Whereas Rydapt must be used alongside chemo, Xospata is currently approved as a monotherapy and is being tested as such and in combination with chemo in the first-line setting. In December, Astellas launched the FLT3-targeting agent in the U.S. at the wholesale acquisition price of $22,500 for a 30-day course. — Angus Liu

52. Xospata

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