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Invivoscribe CDx Assay Gets Expanded FDA Approval Alongside Astellas AML Drug

This article has been updated from a previous version to include information about Japanese reimbursement for Invivoscribe's assay.

NEW YORK (GenomeWeb) – The US Food and Drug Administration said on Wednesday that it has approved an expanded indication for Invivoscribe Technologies' LeukoStrat CDx FLT3 Mutation Assay.

Specifically, FDA expanded approval for LeukoStrat for use with Xospata (gilteritinib), an Astellas Pharma drug for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation.

"Approximately 25 to 30 percent of patients with AML have a mutation in the FLT3 gene. These mutations are associated with a particularly aggressive form of the disease and a higher risk of relapse," Richard Pazdur, director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

Xospata targets the FLT3 gene and is the first drug to be approved that can be used alone to treat patients with AML having a FLT3 mutation who have relapsed or who don't respond to initial treatment, Pazdur added.

FDA granted this application Fast Track and Priority Review designation.

Invivoscribe's LeukoStrat is a PCR-based test is designed to detect internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene. It was previously approved in Japan for predicting patient response to Xospata. It has also been cleared in the US and Europe as a companion diagnostic to Novartis' AML treatment Rydapt (midostaurin).

Yesterday, Invivoscribe said that it submitted the assay to the FDA as a companion diagnostic for Daiichi Sankyo's AML drug quizartinib; and earlier this month it submitted the assay to Japanese regulators as a CDx for the same drug.

Invivoscribe also said on Thursday that the Japanese Ministry of Health, Labour, and Welfare has confirmed national reimbursement for the LeukoStrat CDx FLT3 Mutation Assay.