Oncopeptides Corporate Update
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.
Oncopeptides is now refocusing its resources and energy on R&D and in this capacity it will remain true to its mission of bringing hope to patients through science.
Unfortunately, the commercial business units in the US and Europe will be closed down and the Stockholm based organization will be significantly reduced. The U.S. workforce has already begun the process of downsizing and all U.S. offices will officially close on December 31, 2021.
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 firstname.lastname@example.org 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 email@example.com.