Posted by Michael Wonder on 01 Jul 2020
Oncopeptides submits a new drug application to the FDA for accelerated approval of Melflufen in triple-class refractory multiple myeloma patients
30 June 2020 - Oncopeptides today announces that the Company submits a new drug application to the U.S. FDA for accelerated approval of melflufen (melphalan flufenamide) in combination with dexamethasone for the treatment of adult patients with multiple myeloma whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one anti-CD38 monoclonal antibody.
The results from the HORIZON study demonstrates that melflufen in combination with dexamethasone, has a potential to provide a therapeutic option for patients with relapsed/refractory multiple myeloma that are hard to treat and have a poor prognosis, including patients with triple class refractory myeloma and patients with extra-medullary disease.
