Press release
Oncopeptides Announces Commercial Availability of PEPAXTO® (melphalan flufenamide)
March 15, 2021
BOSTON— March 15, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that PEPAXTO® (melphalan flufenamide) is now commercially available and that the first patients are being treated with the drug. PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, 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.
“Our team has been working diligently to make PEPAXTO available as quickly as possible and now PEPAXTO is ready to ship to academic and regional hospitals as well as community practices,” said Mohamed Ladha, General Manager of the U.S. Business Unit, at Oncopeptides. “Now that drug is available, we are laser focused on making sure that patients who may benefit from PEPAXTO can access treatment. We are proud to offer robust patient assistance programs including financial assistance, insurance navigation assistance, as well as patient support resources.”
Oncopeptides is committed to working with payers and healthcare providers across the United States to help ensure that all patients prescribed PEPAXTO have access to it. Oncopeptides has established a Patient Assistance Program called ON COURSE for people who may not have access to health insurance or have an insurance plan that does not cover the entire cost of the medication. Some restrictions apply and patients need to meet certain eligibility criteria. Additionally, the ON COURSE team offers benefits verification, prior authorization assistance, claims management and appeals. The ON COURSE team is comprised of nurse case managers that offer personalized attention through the treatment process including helping patients and caregivers connect to support groups and organizations in the multiple myeloma community. To learn more please visit www.ONCOURSEsupport.com
Limitation of Use
PEPAXTO is not indicated and is not recommended for use as a conditioning regimen for transplant outside of controlled clinical trials.
To view the full prescribing information please visit https://pepaxto.com/docs/pepaxto_pi.pdf
About Oncopeptides
Oncopeptides is a global biotech company committed to developing targeted therapies for patients facing hard-to-treat hematological diseases. Oncopeptides has one U.S. FDA approved product, PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen. PEPAXTO is approved for patients with triple-class refractory multiple myeloma and was evaluated in several clinical studies including the pivotal Phase 2 HORIZON study and is currently being evaluated in the confirmatory Phase 3 OCEAN study. Oncopeptides’ headquarters is in Stockholm, Sweden, with a U.S. headquarters in Boston, Massachusetts. In addition to Boston, Oncopeptides has a footprint in Los Altos, California, another U.S. biotech hub. For more information, please visit our corporate website at https://oncopeptides.se/en/. You may also visit our U.S. website at https://www.oncopeptides-us.com/en and follow us on our U.S. social media channels, Twitter and LinkedIn.
PEPAXTO® is a trademark of Oncopeptides AB (publ).