Oncopeptides gets FDA accelerated approval for Pepaxto

Swedish biotech Oncopeptides’ (Nasdaq Stockholm: ONCO) shares closed up nearly 9% at 196.10 Swedish kronor yesterday, after it revealed that the US Food and Drug Administration had approved Pepaxto (melphalan flufenamide or ‘melflufen’), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma.

The approval is for patients 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.

Oncopeptides expects Pepaxto to become commercially available in the USA within around two weeks.