Posted by Michael Wonder on 25 Nov 2022
Spectrum Pharmaceuticals receives complete response letter from US Food and Drug Administration for poziotinib
25 November 2022 - Spectrum Pharmaceuticals today announced that the Company has received a complete response letter from the US FDA regarding Spectrum’s new drug application for poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small-cell lung cancer harbouring HER2 exon 20 insertion mutations.
The FDA issued a complete response letter indicating the poziotinib application cannot be approved in its present form. Based on the letter, the Company would have to generate additional data including a randomised controlled study prior to approval.
