US FDA Approves Hanmi Pharm's 'Poziotinib' New Drug Application... Final Hurdle Remains

Final Approval Decision Scheduled for November 24 This Year

[Asia Economy Reporter Lee Gwan-joo] The U.S. Food and Drug Administration (FDA) has approved the new drug application for Hanmi Pharmaceutical's innovative anticancer drug 'Poziotinib' and officially begun its review process.

Hanmi Pharmaceutical's partner, Spectrum, announced on the 12th that the FDA approved the new drug application (NDA) for Poziotinib as a treatment for "locally advanced or metastatic non-small cell lung cancer with HER2 Exon20 insertion mutations" on the 11th.

The FDA emphasized that conducting a confirmatory trial, which corresponds to phase 3 clinical trials, is important for approval and also requested additional information regarding dosage and administration. The FDA also stated that there are currently no plans to hold an advisory committee meeting regarding the NDA.

To date, there are no FDA-approved treatments with the same indication as Poziotinib. This NDA is based on positive results from Cohort 2 (patients with HER2 Exon20 mutation-positive non-small cell lung cancer with prior treatment experience) of the ZENITH20 clinical trial, which evaluated the safety and efficacy of Poziotinib. The FDA is scheduled to decide on the final approval by November 24 under the Prescription Drug User Fee Act (PDUFA).

Tom Lee, President of Spectrum, said, "The FDA's approval of the new drug application is an important step in advancing treatment for HER2 Exon20 insertion mutation lung cancer patients, who have high unmet medical needs due to the lack of special therapies," adding, "We are actively cooperating with the FDA's review process."

Kwon Se-chang, CEO of Hanmi Pharmaceutical, stated, "We have officially entered the final stage for FDA approval of Poziotinib," and added, "We will work more closely with our partner Spectrum to ensure the successful market approval of Poziotinib."

This content was produced with the assistance of AI translation services.