ASTELLAS — Xospata FDA Review (NDA/BLA 211349, 2020)
Astellas Pharma Inc. · 2020 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA approved Astellas Pharma's Xospata (gilteritinib) 40 mg tablets on May 29, 2019, for adult patients with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML). This approval, based on the ADMIRAL trial (Study 2215-CL-0301), addressed a significant unmet medical need. The multidisciplinary review confirmed Xospata's efficacy, demonstrating significantly longer overall survival and higher complete remission rates compared to salvage chemotherapy. The updated prescribing information includes a boxed warning for differentiation syndrome, dosage modifications for toxicities, and comprehensive safety data. Key adverse events include QT prolongation, PRES, and pancreatitis. The FDA's assessment highlighted the drug's benefits while ensuring robust safety labeling.
Key findings — cited to the page
| Grade 3-4 nonhematologic laboratory abnormalities: triglycerides increased | 6 % | XOSPATA (gilteritinib) · p.14 |
| Grade 3-4 nonhematologic laboratory abnormalities: aspartate aminotransferase increased | 10 % | XOSPATA (gilteritinib) · p.14 |
| Grade 3-4 nonhematologic laboratory abnormalities: creatine kinase increased | 6 % | XOSPATA (gilteritinib) · p.14 |
| Grade 3-4 nonhematologic laboratory abnormalities: calcium decreased | 6 % | XOSPATA (gilteritinib) · p.14 |
| Grade 3-4 nonhematologic laboratory abnormalities: creatinine increased | 3 % | XOSPATA (gilteritinib) · p.14 |
| Grade 3-4 nonhematologic laboratory abnormalities: alkaline phosphatase increased | 2 % | XOSPATA (gilteritinib) · p.14 |
| Grade 3-4 nonhematologic laboratory abnormalities: alanine aminotransferase increased | 13 % | XOSPATA (gilteritinib) · p.14 |
| Grade 3-4 nonhematologic laboratory abnormalities: phosphate decreased | 14 % | XOSPATA (gilteritinib) · p.14 |
| Grade 3-4 nonhematologic laboratory abnormalities: sodium decreased | 12 % | XOSPATA (gilteritinib) · p.14 |
| febrile neutropenia (Grade 3 or higher TEAE) | 42.9 % | Xospata (gilteritinib) · p.119 |
| patients with at least 1 Grade 3 or higher TEAE | 93.4 % | Xospata (gilteritinib) · p.119 |
| anemia (Grade 3 or higher TEAE) | 36.1 % | Xospata (gilteritinib) · p.119 |
Source: Astellas Pharma Inc. ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →