EU approves earlier use of Oncopeptides’ Pepaxti
The European Commission has approved an expanded label for Oncopeptides’ Pepaxti (melflufen) in multiple myeloma. The drug can now be used in adults who have received at least two prior lines of therapy and whose disease is refractory to lenalidomide and the last line of therapy.
November 10, 2026
The decision, announced on November 9, confirms the CHMP’s positive opinion from September. It moves Pepaxti from fourth line to third line and removes the previous requirement that patients be triple-class refractory. According to Oncopeptides, this could roughly double the number of eligible patients in Europe. Data from the Phase 3 OCEAN trial showed that patients treated in earlier lines stayed on therapy longer.
Oncopeptides plans to submit its access dossier in Germany within about a month, which allows sales in the third-line setting while benefit assessment and price negotiations proceed. Pricing and reimbursement procedures will follow in other key markets, including Spain and Italy. The company aims to become cash flow positive during 2027.
“The formal approval by the EC is a key milestone and allows physicians to prescribe Pepaxti in earlier lines of therapy, providing its benefit for more patients,” says Sofia Heigis, CEO of Oncopeptides.
Source: Oncopeptides press release, 9 November 2026 — read the release
Published: November 10, 2026
