EC OKs Astellas’ XOSPATA for Relapsed or Refractory Acute Myeloid Leukemia

For twenty-five years, Invivoscribe has improved the quality of healthcare worldwide by providing high quality, standardized reagents, tests, and bioinformatics tools to advance the field of precision medicine. The LeukoStrat^® CDx FLT3 Mutation Assay may now be used as an aid in the assessment of AML patients for treatment with XOSPATA^® (gilteritinib) in Europe. FLT3 mutation must be confirmed with a validated test, such as the LeukoStrat CDx FLT3 Mutation Assay, which served as the companion diagnostic in the Phase 3 ADMIRAL trial resulting in approval of XOSPATA^®.

Companion diagnostics play a key role in the development and approval of targeted drug therapies. The ability to screen for biomarkers in a patient population creates patient subsets which further enables drug developers in the design of novel therapeutics and management of clinical trials. Accordingly, the successful approval of a targeted therapy is highly dependent on the performance of the companion diagnostic.

EC approval of gilteritinib is based on results from the Phase 3 ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3mut+ AML. The ADMIRAL study demonstrated that gilteritinib resulted in a statistically significant improvement in median overall survival (9.3 months) compared to salvage chemotherapy (5.6 months) when patients were selected with the LeukoStrat CDx FLT3 Mutation Assay (Hazard FLT3 Ratio = 0.637 (95%CI 0.488, 0.830, P=0.0004). This approval highlights yet another solution in patient care.

https://www.biospace.com/article/releases/the-european-commission-approves-astellas-xospata-for-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-with-a-flt3-mutation-detected-by-validated-tests-including-the-invivoscribe-leukostrat-cdx-flt3-mutation-assay/