A procedure has begun to designate FDA's Breakthrough Therapy Designation (BTD) for the new anti-cancer drug Poziotinib, developed by Hanmi Pharmaceutical, within this year.
According to a third quarter data released by Spectrum, a partner of Hanmi Pharmaceutical, on October 8 (local time), it has applied to U.S. FDA's BTD. Spectrum said Poziotinib is expected to be designated within this year as an BTD.
The FDA's BTD system first reviews new drug candidates for treatment of life-threatening diseases and approves the clinical results for two phases of the year.
Hannmi Pharmaceutical is currently undergoing a variety of global clinicians to confirm the potential of targeted and primary treatments for EGFR and HER2 20-variable cell lung cancer patients.
