FDA grants orphan drug designation to Kadmon’s tesevatinib for the treatment of EGFR-mutated non-small cell lung cancer.
Kadmon Holdings, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to tesevatinib, the company’s 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.
Kadmon is conducting ongoing Phase 2 clinical trials of tesevatinib for the treatment of EGFR-mutation-positive NSCLC that has metastasized to the brain and/or the leptomeninges (membranes lining the brain and spinal cord) and for the treatment of glioblastoma.
The company is also developing tesevatinib for the treatment of autosomal dominant polycystic kidney disease (ADPKD) and ARPKD and expects to initiate clinical trials in these indications in Q3 2017.
Kadmon Holdings, Inc. is a fully integrated biopharmaceutical company developing products for significant unmet medical needs. We have a diversified product pipeline focused on autoimmune and fibrotic diseases.
(Source: Business Wire)
