The FDA has issued a warning to patients and doctors about the increased chance of death associated with a cancer drug.
The drug, called Pepaxto and made by Sweden-based Oncopeptides AB, received accelerated approval in February to treat patients with multiple myeloma. As part of that conditional OK, Oncopeptides was required to conduct a post-approval phase 3 study. During that trial, the use of Pepaxto combined with dexamethasone was associated with a 10% increase in the chance of death compared to Celgene’s pomalidomide and dexamethasone.
In a statement, the FDA said that it has asked Oncopeptides to halt the enrollment of new patients in the trial and that it will review the continued marketing approval of the drug.
The company reported that it is in an ongoing dialogue with the agency about the drug and that it plans to report complete data about the study at the International Myeloma Workshop meeting in September.
