Astellas Pharma Says U.S. FDA Approves sNDA for Xospata

Astellas Pharma says the U.S. FDA has approved a supplemental New Drug Application to update he U.S. product labeling for XOSPATA to include final analysis data from the ADMIRAL trial.

• Company says Phase 3 ADMIRAL trial showed patients treated with XOSPATA demonstrated longer Overall Survival than those who received salvage chemotherapy
• NOTE April 1 Astellas’ Xospata Boosts Overall Survival in Phase 3

Link to Statement: U.S. FDA Approves Supplemental New Drug Application Adding Overall Survival Data for XOSPATA® (gilteritinib)

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