The FDA issued an alert notifying patients and health care professionals that a clinical trial in patients with multiple myeloma (MM) showed an increased risk for death associated with melphalan flufenamide (Pepaxto, Oncopeptides) in combination with dexamethasone.
The trial (OCEAN, Study OP-103) compared melphalan flufenamide with pomalidomide (Pomalyst, Celgene), both combined with low-dose dexamethasone, in patients with relapsed or refractory MM after two to four lines of therapy and