Oncopeptides has decided to rescind the voluntary withdrawal of Pepaxto® (melphalan flufenamide) in the US based on further review of the overall survival data from the phase 3 OCEAN study (ClinicalTrials.gov Identifier: NCT03151811).
Pepaxto, in combination with dexamethasone, was granted accelerated approval based on response rate for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy and whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 CD38-directed monoclonal antibody. Continued approval for this indication was contingent upon verification and description of clinical benefit in a confirmatory trial.
In October 2021, the Company announced the withdrawal of the drug from the US market after the Food and Drug Administration (FDA) concluded that the OCEAN study did not meet the criteria of a confirmatory trial. Findings showed an increased risk of death in the Pepaxto treatment arm compared with the pomalidomide arm in the intent-to-treat population, 48% (n=117/246) vs 43% (n=108/249), respectively (hazard ratio 1.104; 95% CI, 0.846-1.441).
Since then, an analysis of the OCEAN data, coupled with other clinical trial data, has led the Company to reconsider the request for voluntary withdrawal. Oncopeptides plans to discuss the analyses with the FDA though plans for marketing of Pepaxto in the US are currently on hold.
Oncopeptides rescinds voluntary withdrawal of Pepaxto in the US – no intent to market in the US at this time. News release. January 21, 2022. https://www.prnewswire.com/news-releases/oncopeptides-rescinds-voluntary-withdrawal-of-pepaxto-in-the-us–no-intent-to-market-in-the-us-at-this-time-301465998.html