Hanmi Pharmaceutical "Lung Cancer New Drug Poziotinib Designated as Fast Track by US FDA"

Hanmi Pharmaceutical Headquarters (Provided by Hanmi Pharmaceutical)

[Asia Economy Reporter Chunhee Lee] Spectrum, a partner company of Hanmi Pharmaceutical, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its non-small cell lung cancer treatment 'Poziotinib.'

Hanmi Pharmaceutical announced on the 12th that Poziotinib has been granted Fast Track designation by the U.S. FDA. Spectrum plans to submit a New Drug Application (NDA) for Poziotinib to the FDA by the end of this year.

The FDA implements the Fast Track process to expedite the supply of major new drugs that demonstrate efficacy for serious or life-threatening diseases. When designated as Fast Track, the review period for the marketing approval application is shortened from 10 months to 6 months through priority review, allowing for a faster review process for the approval of the designated drug.

Francois Level, Chief Medical Officer (CMO) of Spectrum, said, “We are actively preparing the marketing approval application for Poziotinib and are pleased with the FDA's Fast Track designation.” He added, “The twice-daily dosing regimen of Poziotinib, recently presented at the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT), demonstrated improved antitumor activity and reduced side effects compared to once-daily administration.”

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