By Colin Kellaher


The U.S. Food and Drug Administration Wednesday said it has ordered Swedish pharmaceutical company Oncopeptides AB to suspend enrollment in clinical trials of its multiple myeloma drug Pepaxto due an increased risk of death observed in a study.

The FDA in February granted accelerated approval of Pepaxto in combination with dexamethasone for certain adults with relapsed or refractory multiple myeloma, but the agency required Oncopeptides to conduct an additional study of the drug, dubbed "OCEAN," as a post-approval requirement.

The agency Wednesday said that due to the "detrimental effect on overall survival in the OCEAN trial," it ordered Oncopeptides to suspend enrollment in studies of Pepaxto, adding that patients receiving clinical benefit from the drug can continue treatment in the OCEAN trial if they are informed of the risks and sign a revised written informed consent.

The FDA also said it is alerting healthcare professionals to review patients' progress on Pepaxto and discuss the risks of continued administration.

Oncopeptides said it has an ongoing dialogue with the FDA, and that will provide updated information as soon as it is available.

The FDA said it continues to evaluate the OCEAN trial results, and that it may hold a public meeting to discuss the study findings and explore the continued marketing of Pepaxto.

Shares of Oncopeptides fell nearly 19% Wednesday to SEK46.42.


Write to Colin Kellaher at


(END) Dow Jones Newswires

July 28, 2021 12:26 ET (16:26 GMT)

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