NEW YORK – Spectrum Pharmaceuticals on Monday said it has submitted a new drug application (NDA) to the US Food and Drug Administration seeking approval for poziotinib as a treatment for advanced non-small cell lung cancer patients with HER2 exon 20 insertion mutations.
The NDA contains data from the multi-cohort ZENITH20 trial, in which 90 patients in cohort 2 received poziotinib and 27.8 percent experienced tumor shrinkage on the treatment. The median duration of response was 5.1 months and median progression-free survival was 5.5 months. Thirteen patients had serious adverse events in the study, and 11 patients discontinued taking the drug due to toxicities.
"The NDA submission for poziotinib marks an important step in achieving a first treatment for patients with HER2 exon 20 insertion mutations in lung cancer," Spectrum CEO Joe Turgeon said in a statement. The FDA has granted fast-track designation to the application.
Poziotinib, discovered by Hanmi Pharmaceutical in South Korea, inhibits EGFR, HER2/neu, and HER4. Hanmi has licensed rights to the drug in China to Luye Pharma and granted rights to the drug in the rest of the world (outside of South Korea and China) to Henderson, Nevada-based Spectrum.