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FDA grants orphan drug designation to tesevatinib for EGFR-mutated non-small cell lung cancer
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The FDA granted orphan drug designation to tesevatinib for the treatment of EGFR-positive non-small cell lung cancer, according to the drug’s manufacturer.
An ongoing phase 2 clinical trial will evaluate tesevatinib (Kadmon Holdings) — an oral tyrosine kinase inhibitor — for the treatment of patients with EGFR-positive NSCLC that metastasized to the brain or the leptomeninges. The trial also will evaluate the agent for the treatment of glioblastoma.
In addition, tesevatinib is in development for the treatment of autosomal dominant polycystic kidney disease and autosomal recessive polycystic kidney disease.
The FDA previously granted orphan drug designation to tesevatinib for the treatment of autosomal recessive polycystic kidney disease in March 2016.
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.
The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.