FDA Flags Increased Death Risk in Studies of Oncopeptides Drug Pepaxto
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
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
Oncopeptides said it has an ongoing dialogue with the FDA, and
that will provide updated information as soon as it is
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
Write to Colin Kellaher at email@example.com
(END) Dow Jones Newswires
July 28, 2021 12:26 ET (16:26 GMT)
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