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# Panel Votes Down Spectrum Lung Cancer Drug
- URL: https://www.fdaweb.com/panel-votes-down-spectrum-lung-cancer-drug/
- Published: 2022-09-22T12:00:00.000Z
- Updated: 2026-09-14T18:00:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152801

FDA’s Oncologic Drugs Advisory Committee 9/22 voted 9-4 against recommending accelerated approval for Spectrum Pharmaceuticals’ Pozenveo (poziotinib) and its use in treating patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring human epidermal growth factor receptor 2 exon 20 insertion mutations. FDA is expected to rule on the application by its 11/24 user fee target date.

Panel members agreed with FDA concerns expressed in a briefing document ([see story](https://www.fdaweb.com/fda-reviewers-question-spectrums-pozenveo/)) with the drug’s low overall response rate, poorly tolerated safety profile at the currently proposed dosage, and inadequate dosage optimization throughout the development program. FDA reviewers said that if the drug is granted accelerated approval, it would be the least effective targeted therapy for lung cancer approved to date.