The U.S. FDA marketing approval process for Poziotinib, a new lung cancer drug developed by Hanmi Pharmaceutical, has begun. Hanmi Pharmaceutical's partner Spectrum announced on the 6th (local time) that it has submitted an NDA to the U.S. Food and Drug Administration (FDA).

This indication is NSCLC with local progression and metastatic HER2 Exon 20 insertion mutation with treatment experience. This NDA submission is based on the positive cohort 2 results of the ZENITH20 clinical trial that evaluated the safety and efficacy of Poziotinib.

Poziotinib was designated as FastTrack by the FDA. As a result of this indication, there are no FDA-approved treatments so far. Spectrum President Joe