The opinion now goes to the European Commission for a final decision.

Oncopeptides’ Pepaxti, in combination with dexamethasone, is currently approved in the EU for adult patients with multiple myeloma who have received at least three prior lines of therapy and are triple-class refractory. Under the newly adopted CHMP opinion, the indication would extend to patients who have received at least two prior lines of therapy (third line and later) and whose disease is refractory to lenalidomide and the last line of treatment. This would remove the triple-class refractory requirement and allow physicians to treat patients earlier in their disease.

“The positive CHMP opinion paves the way for broader patient access and expanded commercial opportunities across Europe,” says Sofia Heigis, CEO of Oncopeptides. “Expanding into the third line removes the triple-class refractory barrier, effectively doubles our addressable patient population, and enables longer treatment duration. If approved by the European Commission, this broader label would significantly unlock potential beyond our current indication and support our path to cash-flow positivity during 2027.”

The recommendation is based on clinical evidence from the Phase 3 OCEAN trial, which demonstrated efficacy and safety in patients with relapsed and refractory multiple myeloma. Earlier-line treatment allows patients to remain on therapy longer, and the average number of treatment cycles per patient in the third line is estimated to double compared with the current fourth-line indication.

A final decision from the European Commission is expected within 30 to 60 days. If the label expansion is approved, Oncopeptides will begin local pricing and reimbursement discussions across Europe. In Germany, existing regulatory frameworks allow for immediate commercial sales under the expanded indication once the access dossier is submitted, which the company plans to do within roughly a month of EC approval.