Oncopeptides announced today that the Melflufen open-label Expanded Access Program, sEAPort, for eligible U.S. patients, is formally open. EAPs are designed to provide patients living with serious or life-threatening conditions access to investigational medicines when no comparable or satisfactory treatment options are available, alternative therapies have been exhausted or the patient is ineligible for ongoing interventional trials.
Melflufen (melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma.
The sEAPort program is available to adults, age 18 and older, who have received at least two prior lines of therapy and whose multiple myeloma is refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients).
Forty to fifty medical sites in the U.S. are expected to enroll 100-200 patients in the sEAPort program.
The Expanded Access Program was initiated following the Company´s June 30 submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of melflufen in combination with dexamethasone for the treatment of adult patients with triple-class refractory multiple myeloma. The NDA and the sEAPort program are primarily supported by data from the pivotal phase 2 HORIZON study, (study results here) which demonstrates that melflufen in combination with dexamethasone, has a potential to provide a therapeutic option for patients with relapsed refractory multiple myeloma who are hard to treat and have a poor prognosis, including patients with triple-class refractory multiple myeloma and patients with extramedullary disease.
The program will enable patients with triple-class refractory myeloma to access melflufen while the drug is under review by the U.S. FDA.”