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Oncologic Drug Advisory Committee

  • IQVIA Solutions Denmark A/S Denmark (map)

The US FDA has scheduled a two-day meeting of the Oncologic Drugs Advisory Committee (ODAC) from September 22-September 23, 2022. On 22nd September 2022, the committee will discuss a NDA 215643, for Poziotinib tablets, submitted by Spectrum Pharmaceuticals, Inc 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 will also hear an update on NDA 214383, for PEPAXTO (melphalan flufenamide) injection, submitted by Oncopeptides for use in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma.