Oncopeptides AB (publ) announces that Pepaxti (melphalan flufenamide, also called melflufen) has been granted marketing authorization in combination with dexamethasone, by the Medicines & Healthcare products Regulatory Agency, MHRA, in UK.
“The approval of Pepaxti in UK is one additional important milestone for Oncopeptides that further validates our science and data,” says Jakob Lindberg, CEO Oncopeptides AB. “Pepaxti provides clinical benefit to patients with triple class refractory disease. This is very good news for patients with multiple myeloma, whose treatment options ultimately become exhausted.”
The marketing authorization in the UK is based on data from the phase 2 HORIZON study and is supported by data from the randomized controlled phase 3 OCEAN study as a confirmatory study.
The clinical benefit of melflufen in multiple myeloma patients with a treatment history with no stem-cell transplant or a successful prior stem-cell transplant has recently gained additional support with data from the phase 3 LIGHTHOUSE 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.
On August 18, Pepaxti was granted marketing authorization by the European Commission in EU and in the EEA-countries Iceland, Lichtenstein, and Norway.
Multiple myeloma is an incurable disease that mainly affects people over 65 years of age. Data from Cancer Research UK (Cancer Research UK, 2010) and the Global Cancer Observatory (Globocan, 2020) states that the estimated prevalence of multiple myeloma is around 17.600 patients. There are around 6.000 new cases diagnosed every year.
Oncopeptides is currently assessing the market access opportunities for Pepaxti in the UK.