FDA Grants Orphan Drug Designation to Tesevatinib for EGFR-Mutated Non-Small Cell Lung Cancer


“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.”

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