Melflufen Access Programs
Oncopeptides is committed to bringing hope to patients through innovative science and transformative medicines. Oncopeptides has established two programs to enable access to melphalan flufenamide (melflufen) for treatment of eligible patients with multiple myeloma who lack other treatment options, and where melflufen is not yet commercially available and are not to be provided through clinical trials.
Early Access Program Europe
Oncopeptides launched an Early Access Program in Europe together with Clinigen in April 2021, in conjunction with the submission of the marketing authorization for melflufen in EU. The purpose was to help address the unmet medical need in patients with relapsed refractory multiple myeloma ahead of commercially available melflufen. When patients cannot be treated satisfactorily with other drugs approved or authorized for marketing, Oncopeptides may consider providing melflufen through an Early Access Program. The program continues to be open to eligible patients – based on local regulations – until the drug will be commercially available.
For more information and guidance how to request melflufen, please contact:
Pre-license Sales Program
In January 2023 Oncopeptides initiated a global pre-license sales program for together with Tanner Pharma Group. Tanner is an exclusive provider of melflufen to patients in countries outside of Europe and the US, where the product is not commercially available. The product will be provided to patients with triple-class refractory multiple myeloma on a named patient basis. If you are a healthcare professional and would like to learn more about the melflufen Pre-License Sale Program, please contact Tanner Pharma Group at the contact details below and you will receive a response within one working day.
For more information and guidance, please contact:
Pepaxti® (melflufen) has been granted full approval by the European Medicines Agency, EMA, and the Medicines and Healthcare Products Regulatory Agency, MHRA, in the UK. The approvals are based on data from the phase 2 HORIZON study and supported by data from the confirmatory phase 3 OCEAN study. Pepaxti is indicated in combination with dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. The company has initiated commercialization in Europe and is conducting and preparing market access activities to gain pricing and reimbursement across the continent.