Published on 11 Feb 2023 on Zacks via Yahoo Finance
Spectrum (SPPI) Down as FDA Panel Votes Against NSCLC Drug
Shares of Spectrum Pharmaceuticals, Inc. SPPI were down 32.6% on Friday after the company announced that the FDA's Oncologic Drugs Advisory Committee (“ODAC”) did not vote in favor of its pipeline candidate, poziotinib, for the treatment of advanced or metastatic non-small cell lung cancer (“NSCLC”) in previously treated patients with HER2 exon 20 mutations on Sep 22.
The ODAC voted nine to four, thus confirming that the current benefits of poziotinib did not outweigh its risks.
SPPI submitted a new drug application (“NDA”) to the FDA for poziotinib back in December 2021 for use in patients with previously treated locally advanced or metastatic NSCLC with HER2 exon 20 insertion mutations.