The European Commission formally issued regulatory approval for a Type II variation application expanding the marketing authorization for Pepaxti (melphalan flufenamide, also known as melflufen) on Tuesday, November 10, 2026, in Brussels. The landmark European administrative decision authorizes the peptide-drug conjugate for adult patients with relapsed and refractory multiple myeloma who have received at least two prior lines of therapy and whose disease is refractory to lenalidomide and the last line of treatment. The regulatory expansion eliminates the restrictive requirement for triple-class refractoriness, advancing Pepaxti into earlier third-line clinical therapy across the European Union.
Oncopeptides CEO cites 6.8-month progression-free survival data
The expanded indication applies across all twenty-seven European Union member states, the European Economic Area countries Iceland, Liechtenstein, and Norway, and the United Kingdom. For adult myeloma patients who underwent prior autologous stem cell transplantation, the updated European summary of product characteristics specifies that time to progression should be at least three years post-transplant to optimize therapeutic outcomes.
Announcing the regulatory authorization at corporate headquarters in Stockholm, Sofia Heigis, Chief Executive Officer of Swedish biotechnology developer Oncopeptides, reviewed the milestone. The executive stated: "Formal approval by the European Commission represents an indispensable therapeutic advance for patients living with relapsed multiple myeloma across Europe. Expanding our label into the third-line setting removes the triple-class refractory barrier, effectively doubling our addressable patient population. Treating patients earlier in their disease trajectory allows individuals to remain on therapy longer and derive superior clinical benefit."
Regulatory approval was supported by comprehensive clinical efficacy and safety findings from the pivotal randomized Phase 3 OCEAN trial alongside supportive real-world registry evidence. In patients with lenalidomide-refractory disease, melflufen combined with dexamethasone demonstrated superior median progression-free survival of 6.8 months per blinded independent review committee assessment, compared with 4.9 months in the pomalidomide comparator arm, reducing the relative risk of disease progression or death by 21 percent.
Oncopeptides plans Germany, Spain and Italy market access
European clinical hematologists and academic oncology societies commended the regulatory decision. In a clinical commentary published on Tuesday, a leading European myeloma research fellow noted: "Relapsed multiple myeloma remains a relentless hematologic malignancy characterized by successive treatment failures. Introducing an aminopeptidase-targeted alkylating agent at third-line intervention allows clinicians to circumvent immunomodulatory drug resistance without escalating cumulative organ toxicities."
Oncopeptides confirmed plans to submit its formal market access dossier in Germany within thirty days, enabling immediate commercial prescribing under national pricing and reimbursement regulations while formal benefit assessments proceed. The biotechnology company will initiate pricing negotiations across Spain and Italy, positioning its commercial oncology portfolio to achieve positive operating cash flow during 2027.
Oncology patient advocacy organizations throughout Europe applauded the European Commission for accelerating therapeutic access for refractory cancer patients. Multi-center academic hospitals confirmed that updated clinical treatment algorithms incorporating third-line Pepaxti protocols will be distributed to regional cancer treatment networks throughout the coming months.
Specialists highlight targeted action and personalized sequences
In addition, clinical hematology specialists and patient advocacy organizations emphasized that peptide-drug conjugate therapies deliver potent targeted cytotoxic action directly to malignant plasma cells while sparing healthy tissue. Broadening European access to third-line Pepaxti empowers oncologists to construct personalized treatment sequences for refractory patients. Medical research institutions look forward to incorporating expanded real-world clinical registry findings into future therapy guidelines.
European oncology specialists and clinical hematology networks confirmed that expanding treatment options for relapsed multiple myeloma significantly improves quality of life for heavily pretreated individuals. In addition, patient advocacy coalitions praised regulatory authorities for broadening access to targeted therapies, empowering clinicians to tailor therapeutic sequences to individual patient clinical profiles. European patient organizations and academic hematology clinics look forward to implementing updated multiple myeloma treatment guidelines to ensure timely patient access.
