Oncopeptides AB (STO:ONCO), a Swedish biotech company focused on difficult-to-treat cancers, said on Monday that it intends to submit a Type II variation application to the European Medicines Agency (EMA) to expand the indication for Pepaxti to include third-line multiple myeloma treatment.

The company said the proposed label expansion would double the addressable patient population for Pepaxti in Europe, with third-line patients also expected to receive around twice as many treatment cycles as those covered under the current indication.

The application is supported by data from the Phase 3 OCEAN study and targets adult patients who have received at least two prior lines of therapy and whose disease is refractory to lenalidomide and the latest treatment line. Oncopeptides previously estimated Pepaxti's market potential in Europe at SEK1.5bn under the existing indication covering fourth-line treatment and beyond.

Chief executive Sofia Heigis said that evolving treatment practices and market experience with Pepaxti support the move into earlier lines of therapy. Oncopeptides expects to submit the application in the coming months, receive initial regulatory feedback before year-end, and obtain a final European Commission decision in the first half of 2027.