Important information regarding PEPAXTO® in the United States
October 22, 2021
Subject: Voluntary withdrawal of PEPAXTO® (melphalan flufenamide) for the treatment of relapsed or refractory multiple myeloma
Dear Healthcare Provider:
This letter is to inform you about important information regarding PEPAXTO in the United States.
On October 22, 2021, Oncopeptides announced the decision to voluntarily withdraw the US accelerated approval for PEPAXTO in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody. You can read the press release HERE.
This difficult decision was made following consultation with the U.S. Food and Drug Administration (FDA) regarding the results of the Phase 3 OCEAN study, which showed an overall survival in the intent-to-treat population with a hazard ratio of 1.104.
At this time, no new patients should begin taking PEPAXTO. If a patient is currently taking PEPAXTO and they are receiving a benefit, Oncopeptides is committed to keeping PEPAXTO available. For a limited time, patients may access PEPAXTO free of charge through the Oncopeptides Patient Assistance Program (PAP). You may access the application for an existing patient to continue receiving PEPAXTO HERE. Please contact OnCourse Patient Support Services at 1-844-300-ONCO (1-844-300-6626) for additional information.
Please consult with your billing/reimbursement practice staff to understand reimbursement considerations regarding PEPAXTO during this time of transition. Your specialty distributor should have forwarded market withdrawal instructions. If you do not hear from them by November 12th, please call your distributor’s customer care line and ask to speak to the Recalls and Withdrawals team.
Company Contact Point
If you have any further questions about the information contained in this letter, please contact Oncopeptides Medical Information at firstname.lastname@example.org.
General Manager, U.S. Business Unit