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News
Europe's drug advisory committee has backed expanding melflufen's approval to earlier-line multiple myeloma treatment. The CHMP issued a positive opinion supporting its use in patients who've had at least 2 prior therapies and are refractory to lenalidomide — down from the current 3-line requirement. A final European Commission decision is expected within 30–60 days.
Europe's drug advisory panel backs earlier use of melflufen in multiple myeloma
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a label expansion for melflufen (Pepaxti), a first-in-class alkylating peptide-drug conjugate, in combination with dexamethasone. The updated indication would allow its use in adult multiple myeloma patients who have received at least 2 prior lines of therapy and are refractory to lenalidomide — a meaningful step down from the current requirement of at least 3 prior lines with triple-class refractory disease.
The recommendation is backed by data from the phase 3 OCEAN trial, which showed melflufen plus dexamethasone improved progression-free survival (PFS) versus pomalidomide plus dexamethasone in lenalidomide-refractory patients. However, overall survival numerically favored the pomalidomide arm. A final European Commission decision is expected within 30–60 days.
By the Numbers:
Why it matters: Removing the triple-class refractory barrier effectively doubles the addressable patient population for melflufen, giving oncologists an additional option earlier in the treatment journey for a disease that remains difficult to manage in relapsed/refractory settings.
