The FDA Oncologic Drugs Advisory Committee on Thursday voted against questions regarding the benefits vs. risks of two cancer treatments for which new drug applications have been filed.
The panel concluded 9-4 that the current benefits of the oral, irreversible tyrosine kinase inhibitor poziotinib do not outweigh its risks for treatment of patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.
Later Thursday, with additional members voting, the committee voted 14-2 that melphalan flufenamide, a peptide conjugated alkylating drug, did not have a favorable benefit-risk
