Spectrum, Hanmi Pharmaceutical’s U.S. partner, said Thursday that Poziotinib, a non-small cell lung cancer treatment, has failed to receive breakthrough therapy designation (BTD) status from the U.S. Food and Drug Administration.

The BTD is a process designed to expedite the development and review of drugs intended to treat a severe condition. Drugs that receive BTD status receive sales approval after completing phase 2 clinical trials for the drug.

The company applied for the BTD based on the interim results of Phase 2 clinical trials conducted by MD Anderson for treating 30 patients with EGFR exon 20 mutation metastatic non-small cell lung cancer with Poziotinib.

“Based on the ongoing phase 2 clinical trial (ZENITH20), we will continue to discuss with FDA for the fastest approval process,” Spectrum CEO Joseph Turgeon said. “There is no change in our development schedule for Poziotinib.”

Spectrum will apply for marketing authorization immediately based on the results of Phase 2 clinical trials. To this end, the company plans to recruit the patients needed in the trial until the first quarter of next year and release an interim report during the second half. ​​​​​​

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