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FDA grants orphan drug designation to tesevatinib for the treatment of EGFR mutated NSLCL

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to tesevatinib, an oral tyrosine kinase inhibitor, for the treatment of non-small cell lung cancer (NSCLC) with epithelial growth factor receptor (EGFR)-activating mutations.

This is the second orphan drug designation for tesevatinib; the first designation was granted in March 2016 for the treatment of autosomal recessive polycystic kidney disease (ARPKD).

The FDA grants orphan designation to promote the development of promising products for rare conditions affecting fewer than 200,000 U.S. patients annually.

It qualifies a company for certain financial benefits, including seven years of market exclusivity following marketing approval, tax credits for clinical research costs, eligibility for Orphan Product grants and the waiver of certain administrative fees.

There are ongoing Phase 2 clinical trials of tesevatinib for the treatment of EGFR-mutation-positive NSCLC that has metastasised to the brain and/or the leptomeninges (membranes lining the brain and spinal cord) and for the treatment of glioblastoma.

Source: BusinessWire



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