CHMP Recommends Moving Oncopeptides' Pepaxti (Melflufen) Peptide-Drug Conjugate to Third-Line Multiple Myeloma in the EU
Oncopeptides announced on Thursday, September 17, 2026 that the European Medicines Agency's CHMP adopted a positive opinion to extend the indication of Pepaxti (melflufen), given with dexamethasone, to adults with multiple myeloma who have had at least two prior lines of therapy and whose disease is refractory to lenalidomide and to the last line of therapy. Pepaxti's current EU label covers fourth-line and later patients whose disease is triple-class refractory, so the change would drop that requirement; the opinion rests on the Phase 3 OCEAN trial, and the European Commission is expected to decide within 30 to 60 days. Oncopeptides CEO Sofia Heigis said the broader label 'effectively doubles' the company's addressable patient population. The FDA withdrew the U.S. approval of the same drug, sold there as Pepaxto, on February 23, 2024, after concluding that the OCEAN confirmatory trial did not confirm its clinical benefit.