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Oncologic Drugs Advisory Committee

October 28

The committee will discuss a new drug application for PEPAXTO (melphalan flufenamide) for injection submitted by Oncopeptides AB, approved under 21 CFR 314.500 (subpart H, accelerated approval regulations), in combination with dexamethasone for the treatment of 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.

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Date:
October 28
Event Category: