FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Grants Orphan Designation to Kadmon’s TKI Tesevatinib

Aug. 14, 2017

The FDA granted a second Orphan Drug designation to tesevatinib, an oral tyrosine kinase inhibitor sponsored by Kadmon Holdings, for treating non-small cell lung cancer tumors with epithelial growth factor receptor-activating mutations.

Kadmon is conducting ongoing Phase II clinical trials of tesevatinib for NSCLC tumors that have metastasized to the brain and spinal cord, as well as for the treatment of glioblastoma.

The first designation was granted in March 2016 for autosomal recessive polycystic kidney disease. The company expects to launch clinical trials in autosomal dominant and autosomal recessive polycystic kidney disease by the end of 2017.

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