Hanmi Pharm "Lung Cancer New Drug Poziotinib Submitted for US FDA Marketing Approval"

[Asia Economy Reporter Seo So-jung] Hanmi Pharmaceutical announced on the 7th that the U.S. Food and Drug Administration (FDA) approval process has begun for its lung cancer new drug 'Poziotinib,' which was developed in-house and licensed out to Spectrum in the United States.

Spectrum submitted a New Drug Application (NDA) to the FDA on the 6th (local time) for the indication of locally advanced and metastatic non-small cell lung cancer with human epidermal growth factor receptor 2 (HER2) exon 20 mutations, based on treatment experience.

This NDA submission is based on the results of cohort 2 of the ZENITH20 clinical trial, which evaluated the safety and efficacy of Poziotinib. Poziotinib has been designated as a Fast Track drug by the FDA, and there are currently no FDA-approved treatments for this indication.