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Hanmi Pharm: “Pozitionib Granted Fast-track Designation by the U.S. FDA”

2021.03.16

Spectrum, Hanmi Pharm's partner company, announced on the 15th that the U.S. FDA has granted the non-small cell lung cancer treatment “Poziotinib” the "Fast-Track" designation.



Hanmi Pharm explained that Spectrum plans to submit a new drug marketing license application (NDA) to the FDA by the end of the year. Fast-track is one of the procedures implemented by the FDA for early delivery of important new drugs to patients.

"Spectrum is busily preparing for Poziotinib's market permit application," noted Francois Lebel, the Chief Medical Officer of Spectrum. He added, "We are pleased with the FDA's fast-track designation; twice-daily use (BID) of Poziotinib has demonstrated improved anti-tumor efficacy and reduced side effects compared to the once-daily method at the European Society for Tumor Research (ESMO TAT)."

"We are pleased that Poziotinib has been granted fast-track designation by the FDA at a time when there is no approved treatment for HER2 Exon20 mutant patients," commented Spectrum CEO Joe Turgeon. "We are approaching a turning point to demonstrate the full potential of Poziotinib."

Source: CNB News