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Poziotinib FDA Approval Status

FDA Approved: No
Generic name: poziotinib
Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer

Poziotinib is a tyrosine kinase inhibitor in development for use in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations.

Development timeline for poziotinib

DateArticle
Nov 25, 2022Spectrum Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Poziotinib
Sep 22, 2022Spectrum Pharmaceuticals Provides Update on Poziotinib Following FDA Oncologic Drugs Advisory Committee Meeting
Feb 11, 2022Spectrum Pharmaceuticals Announces Acceptance of New Drug Application Filing for Poziotinib
Dec  6, 2021Spectrum Pharmaceuticals Submits New Drug Application for Poziotinib
Mar 11, 2021FDA Grants Fast Track Designation to Spectrum Pharmaceuticals’ Poziotinib
Sep 24, 2018Spectrum Pharmaceuticals Announces Release of Updated Poziotinib Data From MD Anderson Phase 2 Study in Non-Small Cell Lung Cancer Patients

Further information

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