Press Release

March 11, 2021
1 min read

FDA grants fast track status to poziotinib for HER2-mutated NSCLC


Press Release

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The FDA granted fast track designation to poziotinib for previously treated patients with non-small cell lung cancer and HER2 exon 20 mutations, according to a press release from the drug’s manufacturer.

Poziotinib (Spectrum Pharmaceuticals) is an orally administered irreversible tyrosine kinase inhibitor targeting EGFR and HER2 with exon 20 insertion mutations.

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Data presented at European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 showed twice-daily dosing of poziotinib improved antitumor activity and reduced toxicity compared with once-daily dosing. Additional data will be presented in April at American Association for Cancer Research Annual Meeting.

“There are currently no approved therapies to treat patients with HER2 exon 20 mutations and we are pleased that the FDA has granted fast track designation for poziotinib,” Joe Turgeon, president and CEO of Spectrum Pharmaceuticals, said in the release. “Momentum is building to unlock the potential of poziotinib.”