• Follow-up Trial of Myeloma Drug 'Flopped,' Says FDA Panel

    3 days ago - By Medscape

    Oncopeptides failed to persuade FDA advisers that a post hoc analysis shows a benefit to its myeloma drug, melphalan flufenamide, which received accelerated approval in early 2021.
    Medscape Medical News
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  • FDA advisory panel votes against drugs for lung cancer, multiple myeloma subgroups

    FDA advisory panel votes against drugs for lung cancer, multiple myeloma subgroups

    3 days ago - By Healio

    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
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  • FDA Panel Rebuffs Poziotinib for NSCLC in 9-4 Vote

    3 days ago - By Medscape

    Most FDA panelists expressed doubts about the strength of evidence regarding the benefits of the experimental drug, especially given available therapies.
    Medscape Medical News
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