Xospata (gilteritinib) from Astellas Pharma is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with a FMS-like tyrosine kinase 3 (FLT3) mutation as detected by an FDA-approved test. In March, Astellas announced that the drug met its primary endpoint in a planned interim analysis of a Phase 3 confirmatory…
Biliary cancer drug candidate wins orphan drug designation from FDA
Cranbury, N.J.–based Rafael Pharmaceuticals has announced that its lead pipeline drug CPI-613 (devimistat) has won orphan drug status from FDA for biliary cancer. The orphan designation extends the orphan drug status for devimistat, including pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, Burkitt’s lymphoma, peripheral T-cell lymphomas, and soft tissue sarcoma. The Europe Medicines Agency has…
Oxford Gene Technology expands next-generation sequencing line
Oxford Gene Technology (OGT) has expanded its SureSeq line of next-generation sequencing (NGS) panels to detect genetic variants associated with breast and ovarian cancer and myeloid disorders. One of the offerings is a myeloid panel that can detect abnormalities in 70 genes associated with a range of diseases, including acute myeloid leukemia, myelodysplastic syndrome and…