Tesevatinib Gains Orphan Drug Status for EGFR-Mutation Positive NSCLC
Kadmon Holdings announced that tesevatinib has been granted Orphan Drug designation by the Food and Drug Administration (FDA) to treat non-small cell lung cancer (NSCLC) with epithelial growth factor receptor (EGFR)-activating mutations.
Tesevatinib, an oral reversible and potent tyrosine kinase inhibitor, is currently being assessed in Phase 2 clinical trials for the treatment of EGFR-mutation-positive NSCLC that has metastasized to the brain and/or the leptomeninges and also for the treatment of glioblastoma.
In March 2016, tesevatinib was designated Orphan Drug status for the treatment of autosomal recessive polycystic kidney disease (ARPKD).
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