The regulator has approved Pepaxti in combination with dexamethasone to treat adult multiple myeloma patients who have received at least three lines of therapies previously, whose disease is refractory to at least one immunomodulatory agent, one proteasome inhibitor, and one anti-CD38 monoclonal antibody.
The drug is also approved to treat adult patients who have showed disease progression on or after the last therapy.
A lipophilic peptide conjugated alkylating drug, pepaxti quickly and selectively delivers cytotoxic agents into tumour cells.
It is composed of a di-peptide and an alkylating moiety and inhibits proliferation and induces apoptosis of hematopoietic and solid tumour cells.
Oncopeptides CEO Jakob Lindberg said: “The approval of Pepaxti in Europe is foundational for Oncopeptides, and brings excellent news for patients and shareholders.
“Despite the introduction of novel therapies, patients with triple class refractory disease have a high unmet medical need, since their treatment options ultimately become exhausted.”
The regulatory approval is based on findings obtained from the Phase II HORIZON study, and the randomised controlled Phase III OCEAN study as confirmatory study.
The HORIZON study was conducted in 157 relapsed or refractory multiple myeloma patients.
It has assessed melflufen and dexamethasone combination in heavily pre-treated patients with poor prognosis.
The EC marketing approval enables the sale of Pepaxti in all EU member states, along with the European Economic Area (EEA) countries Norway, Iceland, and Lichtenstein.
Furthermore, the company plans to submit a type II variation of the drug in the fourth quarter of this year to provide access to earlier lines of treatment for RRMM patients.