Posted by Michael Wonder on 14 Feb 2022
Spectrum Pharmaceuticals announces acceptance of new drug application filing for poziotinib
11 February 2022 - Spectrum Pharmaceuticals today announced that its new drug application for poziotinib has been accepted for review by the U.S. FDA.
The new drug application acceptance is based on the positive Phase 2 study results in patients with previously treated locally advanced or metastatic non-small-cell lung cancer harbouring HER2 exon 20 insertion mutations. There is currently no treatment specifically approved by the FDA for this indication.
The product has received fast track designation and the agency has set a Prescription Drug User Fee Act date of 24 November 2022.
