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Spectrum Pharma (SPPI) says FDA committee voted 9-4 that current benefits of poziotinib did not outweigh its risks

September 22, 2022 3:32 PM EDT

Spectrum Pharmaceuticals (NasdaqGS: SPPI) (Spectrum or the Company), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administrations (FDA) Oncologic Drugs Advisory Committee (ODAC) met to review poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 exon 20 insertion mutations. The committee voted 9-4 that the current benefits of poziotinib did not outweigh its risks.

We are disappointed by the outcome of the ODAC meeting, as patients with NSCLC HER2 exon 20 insertion mutations are in need of... More