Oncologic Drugs Advisory Committee Meeting negative on poziotinib for the treatment of patients with non-small cell lung cancer harboring HER2 exon 20 insertion mutations
Spectrum Pharmaceuticals announced that the FDA's 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 additional effective and safe therapies,” stated Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. “We plan to carefully evaluate our options for this program as we approach the November 24, 2022, PDUFA date. We would like to thank lung cancer patients and their families, as well as investigators and their staff, for their support.”
ODAC is an independent panel of experts that reviews and evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer. The committee makes appropriate recommendations to the FDA, but these recommendations are not binding and the final decision regarding product approval will be made solely by the FDA.
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