6 December 2021 - Fast track application is based on positive data in NSCLC HER2 exon 20 insertion mutations in previously treated patients.

Spectrum Pharmaceuticals today announced that it has submitted its new drug application for poziotinib to the U.S. FDA for use in patients with previously treated locally advanced or metastatic non-small-cell lung cancer with HER2 exon 20 insertion mutations. 

The submission is based on the positive results of Cohort 2 from the ZENITH20 clinical trial, which assessed the safety and efficacy of poziotinib.

Read Spectrum Pharmaceuticals press release