Europe Clears Oncopeptides' Myeloma Drug for Earlier Third-Line Use

The European Commission handed Oncopeptides a broader label on Nov. 9, 2026. Melphalan flufenamide, given alongside dexamethasone, can now be prescribed to adults with relapsed or refractory multiple myeloma after at least two prior lines of therapy, shifting the drug from the fourth-line setting into third-line treatment and beyond.

The rewrite also scraps the old rule that patients had to be refractory to three major myeloma drug classes. That requirement had confined the therapy to triple-class refractory patients who had already failed three or more lines. The decision formally confirms the positive opinion issued by the European Medicines Agency's Committee for Medicinal Products for Human Use.

Supporting evidence comes from the Phase 3 OCEAN trial, which tested melphalan flufenamide plus dexamethasone against pomalidomide plus dexamethasone in 495 patients who had tried two to four prior lines. Median progression-free survival hit 6.8 months versus 4.9 months. Overall survival did not improve across the full trial population, at roughly 19.8 months versus 25.0 months, and hematologic toxicity was substantial. Regulators weighed that benefit-risk balance in a more tightly defined eligible group, including a restriction tied to prior autologous stem cell transplantation.

Melphalan flufenamide is a peptide-drug conjugate carrying an alkylating agent designed to deliver cytotoxic activity into cancer cells. Its notable adverse effects include thrombocytopenia, neutropenia, anemia and infections. Oncopeptides says removing the triple-class refractory bar could roughly double the eligible patient population across Europe, and that third-line patients average about twice as many treatment cycles as those treated in the fourth-line setting. CEO Sofia Heigis stressed the significance of the decision.

The company links the expansion to commercial growth and its aim of reaching positive cash flow during 2027. In Germany, Oncopeptides plans to submit a market access dossier in about a month, which would let commercial sales begin while health technology assessment and pricing negotiations proceed. Spain and Italy will move on their own national pricing and reimbursement timelines, and the company is weighing opportunities in additional European markets.

Actual patient access still depends on national reimbursement arrangements and local clinical practice. The European win sits in sharp contrast to the US, where the Food and Drug Administration withdrew its approval in February 2024, concluding the confirmatory study had not verified clinical benefit and the evidence did not establish safety and effectiveness under its US conditions of use. European regulators reached a different benefit-risk conclusion for a more specifically defined population.