Oncopeptides has announced that the European Commission has granted Pepaxti marketing authorization in combination with dexamethasone.
The approval concerns 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 approval of Pepaxti in Europe is foundational for Oncopeptides, and brings excellent news for patients and shareholders,” says Jakob Lindberg, CEO Oncopeptides. “Despite the introduction of novel therapies, patients with triple class refractory disease have a high unmet medical need, since their treatment options ultimately become exhausted.”
The marketing authorization is valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Lichtenstein, and Norway.
The phase 2 HORIZON study
The marketing authorization is based on data from the phase 2 HORIZON study and is supported by data from the randomized controlled phase 3 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).
Oncopeptides will now advance market access activities to pave the way for a launch of Pepaxti in Germany in Q4, 2022. The company is dedicated to making the drug available for patients across Europe and is actively considering various options to commercialize the product, it states.
Photo of Jakob Lindberg: Oncopeptides