FDA alerts patients and health care professionals about clinical trial results showing an increased risk of death associated with Pepaxto (melphalan flufenamide)
[7/28/2021] FDA is alerting patient s and Health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto ( melphalan flufenamide ) with dexamethasone to treat patient s with multiple myeloma showed an increased risk of death . The trial compared Pepaxto with low-dose dexamethasone to pomalidomide with low-dose dexamethasone in patients with relapsed or refractory (resistant) multiple myeloma following 2-4 lines of prior therapy and in patients who were resistant to lenalidomide in the last line of therapy. FDA encourages health care professionals to review patients’ progress on Pepaxto and discuss the risks of continued administration with each patient in the context of other treatments. Patients currently receiving Pepaxto should also discuss with their health care professional the...