Oncopeptides submits EMA application for Pepaxti label expansion to third-line treatment

CAR-T Digest - August 2020

12 June 2026: Oncopeptides submits EMA application for Pepaxti label expansion to third-line treatment

Oncopeptides has submitted a type 2 variation application to the European Medicines Agency seeking to expand the label of Pepaxti into the third-line treatment setting for relapsed/refractory Multiple myeloma, marking an important regulatory step toward broader use of the therapy in Europe
The application is supported by data from the phase 3 OCEAN study and seeks to expand Pepaxti’s indication to include adult Multiple myeloma patients who have received at least two prior lines of therapy and whose disease is refractory to Lenalidomide and the last line of treatment, moving the therapy earlier in the treatment paradigm
The submission has been validated by the EMA, with the formal regulatory review process scheduled to begin in June 2026, representing a key milestone in the company’s efforts to broaden Pepaxti’s commercial and clinical reach
Pepaxti is a first-in-class peptide-drug conjugate that selectively delivers melphalan into myeloma cells and is currently approved in Europe in combination with Dexamethasone for heavily pretreated Multiple myeloma patients, offering a differentiated mechanism of action in a challenging treatment setting
Strategically, a successful label expansion could approximately double Pepaxti’s addressable patient population in Europe and allow treatment earlier in the disease course, strengthening Oncopeptides’ competitive position in Multiple myeloma while enhancing the long-term commercial potential of its peptide-drug conjugate platform