Pepaxti®
Melphalan Flufenamide
Pepaxti (melphalan flufenamide) is a Peptide Drug Conjugate (PDC) with an alkylating payload, developed for the treatment of adult patients with multiple myeloma. It has been granted full approval by the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA).
The approvals are based on data from the phase 2 HORIZON study and supported by the confirmatory phase 3 OCEAN study. Pepaxti is indicated in combination with dexamethasone for adult patients with multiple myeloma who have received at least three prior lines of therapy and whose disease is refractory to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have progressed on or after their last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.
*(SmPC) from the European Medicines Agency (EMA)
Patient access programs
Oncopeptides offers access programs for melphalan flufenamide in situations where it is not yet commercially available and is not provided through clinical trials.
Early Access Program (Europe)
Provides melphalan flufenamide to eligible patients in Europe under local regulations until commercial availability.
Contact: eap@oncopeptides.com
Pre-license Sales Program
In collaboration with Tanner Pharma Group, this program supports access for eligible patients in countries outside Europe and the US.
Contact: maccess@tannerpharma.com
Current regulatory status
The regulatory status provides current information on the Company’s marketing authorizations and regulatory submissions.
Europe
Pepaxti has been granted Marketing Authorization in the European Union, including the EEA-countries Iceland, Lichtenstein and Norway, by the European Commission on August 17, 2022. The product was approved by the Medicines and Healthcare products Regulatory Agency, MHRA, in the UK on November 11, 2022.
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.