Spectrum, Hanmi Pharmaceutical’s U.S. partner, said Thursday that it has applied for breakthrough therapy designation (BTD) status for Poziotinib, a non-small cell lung cancer treatment, to the U.S. Food and Drug Administration.
The Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a severe condition. Drugs that receive BTD status receive sales approval after completing phase 2 clinical trials for the drug.
The company expects to receive such a status by the end of this year.
Hanmi Pharmaceutical licensed Poziotinib to Spectrum in 2015. The drug is undergoing various global clinical trials to treat patients with EGFR and HER2 exon 20 mutations in non-small cell lung cancer, including phase 2 clinical trials, to become a first-line therapy.