Other safety alerts
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| The United States: FDA alerts patients and health care professionals about clinical trial results showing an increased risk of death associated with Pepaxto (melphalan flufenamide): Update |
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The US Food and Drug Administration (FDA) announces an update on Pepaxto (melphalan flufenamide). FDA’s Center for Drug Evaluation and Research (CDER) has provided Oncopeptides AB (the manufacturer) notice of its proposal to withdraw accelerated approval of Pepaxto (melphalan flufenamide) because the post-approval confirmatory trial required as a condition of Pepaxto’s approval failed to verify clinical benefit and available evidence demonstrates Pepaxto is not shown to be safe or effective under its conditions of use.
An Oncologic Drugs Advisory Committee (ODAC) was held on 22 Sep 2022 to discuss the results of the OCEAN confirmatory trial and the benefit-risk profile of Pepaxto for the indicated population. The ODAC voted 14 to 2 that the benefit-risk profile of melphalan flufenamide was not favorable for the currently indicated patient population, given the results of the OCEAN confirmatory trial.
Pepaxto is not currently being marketed in the United States.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-about-clinical-trial-results-showing-increased
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 29 Jul 2021.
Ends/Friday, Aug 25, 2023
Issued at HKT 14:00
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