European Commission Widens Pepaxti Label for Earlier Myeloma Treatment
The European Commission has approved a wider label for Oncopeptides' multiple myeloma drug Pepaxti, moving it from fourth-line to third-line treatment. The company announced the decision on November 9, 2026, and says it removes a requirement that limited eligible patients.
The European Commission approved a wider label for the cancer drug Pepaxti (melflufen) on November 9, 2026, according to its maker, Oncopeptides AB. The European Commission approves label changes that let doctors use the drug earlier in treatment of multiple myeloma, a blood cancer.
The Stockholm-based company, listed on Nasdaq Stockholm under the ticker ONCO, said the Commission formally approved a Type II variation application. That is a regulatory change to an existing marketing authorization.
Pepaxti is now cleared for adults with multiple myeloma who have received at least two prior lines of therapy. Their disease must be refractory to lenalidomide and to the last line of therapy. Refractory means the cancer has stopped responding.
What changes for patients
The drug was previously approved only in the fourth-line setting. The new label moves it to third line and later. It also removes the requirement that patients be triple-class refractory.
The decision confirms a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency. Oncopeptides said the approval was anticipated after that recommendation.
The company said the expanded indication rests on data from the Phase 3 OCEAN trial, plus safety data from several clinical trials and real-world use. It said the data show earlier treatment can enable longer disease control and prolonged treatment duration.
Commercial plans
Sofia Heigis, chief executive of Oncopeptides, called the approval "a key milestone" that lets physicians prescribe Pepaxti "in earlier lines of therapy." She said the broader indication "has the potential to double the addressable patient base."
Heigis said the company can use its existing commercial footprint to scale the drug cost-effectively. She said this supports its ambition to become cash flow positive during 2027.
The company also said earlier-line treatment roughly doubles the average number of treatment cycles per patient in third line compared with fourth line.
In Germany, Oncopeptides plans to submit its access dossier within about one month. That allows immediate commercial sales in the third-line setting while benefit assessment and price negotiations continue.
The company said formal pricing and reimbursement procedures will follow in other key markets, including Spain and Italy, on local submission schedules. It is also examining how the new label could be used in additional markets.
