FDA Approves NDA for Poziotinib from Hanmi Pharm and Begins Official Review
The US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for sale and marketing of first-in-class anti-cancer drug, Poziotinib, developed by Hanmi Pharmaceutical in the United States and has begun an official review.
Hanmi Pharm’s partner, Spectrum Pharmaceuticals, announced on February 11 that the FDA had approved the NDA for Poziotinib as a “treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon20 insertion mutation” and begun the official process for marketing approval.
To date, there have not been any FDA-approved treatment for the same indication as Poziotinib, the NDA for which was filed based on Cohort 2 (HER2 exon 20 mutation-positive NSCLC who have received treatment in the past) in ZENITH20, a clinical study conducted to evaluate the safety and efficacy of Poziotinib. The FDA will make its decision on final approval by November 24 this year in accordance with the Prescription Drug User Fee Act (PDUFA).
According to Hanmi Pharm, the FDA stated that it is important to proceed with a confirmatory trial, which corresponds to a Phase 3 clinical trial for approval, and requested additional information regarding the drug dosage and directions. The FDA is also not planning to hold an advisory committee meeting on the NDA.
“The FDA approval of the New Drug Application is a crucial step in advancing the treatment of patients with HER2 exon20 insertion mutation-positive lung cancer, for which there is an unmet demand because there is no specific treatment at present,” said Tom Riga, CEO of Spectrum Pharmaceuticals. Kwon Se-chang, CEO of Hanmi Pharm, said, “We have officially entered the final gateway for FDA approval of Poziotinib. [...] We will work closely with our partner, Spectrum, for successful marketing approval of Poziotinib.”