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# Spectrum NDA Accepted for HER2 Lung Cancer
- URL: https://www.fdaweb.com/spectrum-nda-accepted-for-her2-lung-cancer/
- Published: 2022-02-14T12:00:00.000Z
- Updated: 2026-09-14T17:32:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151153

FDA has accepted for review a Spectrum Pharmaceuticals NDA for poziotinib and its use in treating patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The user fee review action target date is 11/24.

The company is seeking accelerated approval and FDA has reportedly told it that it is important to have a confirmatory trial substantially enrolled at the time of approval and requested additional information around dosing. The agency also said it is not currently planning to hold an advisory committee meeting for the submission.

The submission is based on data from a Phase 2 study in 90 patients who received an oral once daily dose of 16 mg of poziotinib. The intent-to-treat analysis demonstrated a confirmed objective response rate of 27.8%, the company says. “The median duration of response was 5.1 months and the median progression free survival was 5.5 months,” it says. “In this cohort, 87% of patients had drug interruptions with 11 patients (12%) permanently discontinuing due to adverse events. 13 patients (14%) had treatment-related serious adverse events.”