Hanmi Pharmaceutical’s smart plant in Paltan-myeon, Hwaseong, Gyeonggi Province (Hanmi Pharmaceutical)
Hanmi Pharmaceutical said Friday that its non-small cell lung cancer treatment Poziotinib has received the fast track designation from the US Food and Drug Administration.
Hanmi added that its US partner Spectrum Pharmaceuticals would submit the new drug application to the FDA by the end of this year.
Fast track designation from the US FDA is one of the measures designed to support development and expedite the review of drugs that show promise in treating serious and address unmet medical needs.
According to Hanmi, the review process for Poziotinib, which follows after the submission of the new drug application, is expected to be reduced to six months from 10 months.
Spectrum CEO Joe Turgeon welcomed the fast track designation and expressed hopes for the company‘s anti-tumor agent to soon become available for lung cancer patients with the HER2 Exon 20 mutation, for whom there is no approved treatment.
Earlier in March, Spectrum revealed its clinical study result that shows the safety and efficacy of Poziotinib in lung cancer patients with the mutation at the ESMO Targeted Anticancer Therapies Virtual Congress 2021.
By Shim Woo-hyun (email@example.com