CHMP Issues Positive Opinion for Pepaxti Label Expansion to Third-Line Treatment
核心洞察
The EMA's CHMP has adopted a positive opinion recommending expansion of Pepaxti's EU indication to third-line and later multiple myeloma (搜索), with a final European Commission decision expected in 30 to 60 days.
The new label would cover adults with at least two prior lines of therapy whose disease is refractory to lenalidomide and the last line, removing the current triple-class refractory requirement.
The recommendation rests on Phase 3 OCEAN data, which Oncopeptides (搜索) says show earlier-line treatment roughly doubles the average number of cycles per patient versus the fourth-line indication.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (搜索) has adopted a positive opinion recommending an extension of the therapeutic indication for Pepaxti (melflufen) to earlier lines of therapy in multiple myeloma (搜索). The opinion now goes to the European Commission for a final decision.
Under the adopted opinion, Pepaxti in combination with dexamethasone would be indicated for adults with multiple myeloma (搜索) who have received at least two prior lines of therapy (third line and later) and whose disease is refractory to lenalidomide and the last line of therapy. Pepaxti is currently approved in the EU for adults who have received at least three prior lines and are triple-class refractory (fourth line and later). Moving to third line removes the triple-class refractory requirement, which Oncopeptides (搜索) says effectively doubles the addressable patient population and allows longer treatment duration.
The recommendation is based on clinical evidence from the Phase 3 OCEAN trial in relapsed and refractory multiple myeloma (搜索). Earlier-line treatment is estimated to double the average number of treatment cycles per patient in third line compared with the current fourth-line indication. A European Commission decision is anticipated within 30 to 60 days, after which Oncopeptides (搜索) plans local pricing and reimbursement discussions across Europe and, in Germany, submission of an access dossier within roughly one month of approval to allow immediate commercial sales under the expanded indication.