In halting confirmatory trial for Oncopeptides' accelerated approval, FDA notes increased risk of death
The FDA on Wednesday morning alerted patients and healthcare professionals that the confirmatory trial for Oncopeptides’ multiple myeloma drug Pepaxto (melphalan flufenamide) has been halted, as the combination of Pepaxto and dexamethasone showed an increased risk of death.
The confirmatory trial, required as a condition of Pepaxto’s accelerated approval in February and known as OCEAN, compared Pepaxto and low-dose dexamethasone with Bristol Myers Squibb’s Pomalyst (pomalidomide) with low-dose dexamethasone in patients with relapsed or refractory multiple myeloma, following 2-4 lines of prior therapy and in patients who were resistant to lenalidomide in the last line of therapy.
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