Important information regarding PEPAXTO® in the United States

December 15, 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.

Information for Prescribers​

With the US withdrawal, there is no marketing authorization for melphalan flufenamide anywhere in the world. 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 medinfo@oncopeptides.com to obtain further instructions about this process.​

Company Contact Point

If you have any further questions about the information contained in this letter, please contact Oncopeptides Medical Information at 1-866-522-8894 or medinfo@oncopeptides.com.