FDA issues alert on increased risk of death associated with Pepaxto

The US Food and Drug Administration today alerted patients and health care professionals that a clinical trial (OCEAN, Study OP-103) evaluating Pepaxto (melphalan flufenamide) with dexamethasone to treat patients with multiple myeloma showed an increased risk of death.

The trial compared Pepaxto, from Swedish biotech Oncopeptides (Nasdaq Stockholm: ONCO), 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.

As a result of the FDA announcement, Oncopeptides’ shares slumped 18.7% to 46.40 Swedish kroner by close of trading today.