- The stock price of Spectrum Pharmaceuticals (SPPI) fell by over 27% after hours in the most recent trading session. This is why.
The stock price of Spectrum Pharmaceuticals (SPPI) fell by over 27% after hours in the most recent trading session.
Why: Spectrum Pharmaceuticals announced that the U.S. Food and Drug Administration’s (“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 had voted 9-4 that the current benefits of poziotinib did not outweigh its risks.
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. And 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.
“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. 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.”
— Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals