EU approves Pepaxti in multiple myeloma with at least three prior lines of therapies
Oncopeptides AB announced that the European Commission has granted Pepaxti (melphalan flufenamide, also called melflufen) marketing authorization in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy
For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.
The marketing authorization is based on data from the phase II HORIZON study and is supported by data from the randomized controlled phase III OCEAN study as confirmatory study. Oncopeptides intends to submit a type II variation in Q4 2022 to enable access to earlier lines of treatment for patients with relapsed refractory multiple myeloma (RRMM).
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