Important information regarding PEPAXTO® in the United States
March 1, 2022
In January 2022, Oncopeptides rescinded the October 22, 2021, letter requesting voluntary withdrawal of the NDA of Pepaxto® (melphalan flufenamide) in the US.
Further review and analyses of the heterogenous Overall Survival data from the phase 3 OCEAN study, and other relevant trials, have led the Company to reconsider its previous voluntary withdrawal. Oncopeptides has discontinued the marketing of Pepaxto in the US and it will not be marketed until a mutual understanding on how to interpret the data has been reached with the FDA.
Oncopeptides is committed to provide patients continued access to melphalan flufenamide via the Individual Patient Expanded Access Investigational Drug Application (IND) process if deemed appropriate by their treating physician.
Please contact Oncopeptides Medical information at firstname.lastname@example.org for further information.