Oncopeptides Wins EU Approval to Expand Pepaxti Label for Third-line Treatment

08:33 AM EST, 11/09/2026 (MT Newswires) -- The European Commission approved Oncopeptides' (ONCO.ST) cancer drug Pepaxti for third-line treatment of adults with multiple myeloma. The Swedish biotechnology company said Monday that the label expansion covers patients who have received at least two previous lines of therapy and whose disease is resistant to lenalidomide and the last treatment line. It also removes the previous requirement for triple-class refractoriness. The approval is based on the Phase 3 OCEAN trial data showing that earlier use of Pepaxti can extend disease control and treatment time in relapsed and refractory multiple myeloma. Meanwhile, Oncopeptides will file an access dossier for the drug in Germany within a month and pursue pricing and reimbursement in other European markets, including Spain and Italy.