Astella's XOSPATA™ (gilteritinib) Approved in the EU for Relapsed or Refractory FLT3-Mutated AML with Companion Diagnostic LeukoStrat® CDx FLT3 Mutation Assay
Astellas
Pharmaceutical R&D Manufacturer
Invivoscribe
Hematological Tumor Testing Products and Services Provider
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
10Month30Day,Invivoscribe, Inc.Announced, the European Commission(EC)Approved Astellas DrugsXOSPATA™(gilteritinib)As monotherapy for the treatment of relapsed or refractory acute myeloid leukemia(AML)Adult patients, this therapy adoptsInvivoscribeofLeukoStrat®CDxFLT3Mutation AssayFor testingFLT3Mutation(FLT3mut+)。
LeukoStratTesting, as a testing menu service, can be accessed viaInvivoscribeSubsidiariesLabPMM LLC(San Diego, California, USA),LabPMM GmbH(Martinsried, Germany) andLabPMM GK(Kawasaki City, Japan) obtained.LeukoStrat CDxFLT3Mutation AssayThe kit is currently available in Europe, Japan, Switzerland, and Australia, with plans for future launch in the United States and China.
InvivoscribeCo-developed with AstellasLeukoStrat CDxFLT3Mutation Assay, as an auxiliary diagnostic method to predict patient response to Astellas PharmaAMLDrugXOSPATA (gilteritinib fumarate)response. This approval is based on3PhaseADMIRALResults of the trial, which was conducted in patients with relapsed or refractoryFLT3mut+ AMLstudied in patientsgilteritinibCompared with the efficacy of salvage chemotherapy. UsegilteritinibThe overall survival of patients receiving treatment was significantly longer than that of patients receiving salvage chemotherapy. ReceivinggilteritinibThe median overall survival of treated patients was9.3months, whereas the mean overall survival for patients receiving only salvage chemotherapy was5.6months.
This milestone furtherLeukoStrat CDxFLT3Mutation AssayDesignated as critical typeAMLPatients underwent comprehensiveFLT3the international gold standard for assessment, thisCDxSimultaneous IdentificationITDandTKDFLT3Mutations (including internal tandem duplications) have been marketed globally.
Previously,InvivoscribeofLeukoStrat CDxFLT3Mutation AssayIt has also received multiple regulatory approvals as AstellasXOSPATA (gilteritinib fumarate)NovartisRYDAPT(Midostaurin) and Daiichi Sankyoquizartinib hydrochloride. as an auxiliary diagnostic method.
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