Oncopeptides Files EMA Type II Variation to Expand Pepaxti (Melflufen) Peptide-Drug Conjugate Label to Third-Line Multiple Myeloma
Oncopeptides AB announced May 11-12 it intends to submit a Type II variation application to the European Medicines Agency to expand the Pepaxti (melflufen) label to include third-line treatment of relapsed/refractory multiple myeloma. Pepaxti is one of two FDA-approved peptide-drug conjugates currently on market (the other being Novartis's 177Lu-dotatate Lutathera) and acts as a melphalan-flufenamide alkylating peptide that exploits aminopeptidase enzymes overexpressed in myeloma plasma cells to selectively release the cytotoxic payload inside tumor cells. The Pepaxti EMA label currently covers heavily pre-treated (≥4 prior lines) RRMM; the new third-line expansion submission would meaningfully extend the eligible population. The filing positions the PDC modality for a broader regulatory footprint as the broader peptide-drug-conjugate field heads into ASCO 2026.