FDA’s Oncologic Drugs Advisory Committee to Discuss Three NDA Cancer Drugs
The FDA has scheduled a meeting of its Oncologic Drugs Advisory Committee on Sept. 22 and 23 to discuss New Drug Applications (NDA) for three cancer drugs.
The committee will consider an updated NDA from Oncopeptides for its injectable drug Pepaxto (melphalan flufenamide), which the FDA granted accelerated approval in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody.
A postmarket trial of Pepaxto delivered disappointing results.
The committee will also discuss the NDA for Secura Bio’s Copiktra (duvelisib) capsule drug for use in the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies. The panel will look at the drug’s benefits and risks based on updated overall survival information and safety data.
The expert panel will also discuss Spectrum Pharmaceuticals’ NDA for poziotinib tablets for treatment of patients with previously treated, locally advanced or metastatic nonsmall-cell lung cancer harboring human epidermal growth factor receptor 2 (HER2) exon 20 insertion mutations.