Hanmi Pharmaceutical said it would begin a local phase 3 trial of poziotinib to treat a certain type of non-small cell lung cancer (NSCLC). Attention is on whether the drugmaker will complete the confirmatory trial, a condition required by the U.S. FDA to obtain marketing approval.

On Tuesday, the Ministry of Food and Drug Safety authorized Hanmi to conduct the local phase 3 study of poziotinib (ingredient: poziotinib hydrochloride) in patients with locally advanced or metastatic NSCLC who have been previously treated and who have HER2 exon 20 insertion mutations.

Hanmi developed poziotinib as an NSCLC treatment. Hanmi’s partner Spectrum Pharmaceuticals has the right to commercialize the drug in the global market, except for Korea and China.

In February, Spectrum submitted a new drug application (NDA) for poziotinib to the FDA based on the global phase 2 ZENITH20 trial results.

The FDA must decide on poziotinib approval on Nov. 24 under the Prescription Drug User Fee Act (PDUFA).

When accepting the NDA for poziotinib, the FDA requested Spectrum to conduct a phase 3 confirmatory trial and submit additional information on usage and dosage.

Spectrum is testing poziotinib in a phase 3 study in the U.S., and the phase 3 trial in Korea is part of the confirmatory trial.

Hanmi will conduct the local trial because Hanmi has the right to develop the drug in Korea.

However, Hanmi refused to comment on the schedule for a marketing approval application in Korea.

“The local phase 3 trial of poziotinib is part of the phase 3 study in the U.S. The study is progressing as scheduled,” an official at Hanmi said.