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On May 25, 2021, positive topline results from the phase III OCEAN study (NCT03151811) of melphalan flufenamide (melflufen) for the treatment of relapsed/refractory multiple myeloma (RRMM) were released. These results demonstrated that melflufen was at least as efficacious as pomalidomide for this indication.1
Based on these data, a supplementary new drug application to move to earlier lines of therapy is planned to be submitted to the FDA in the last quarter of 2021.
EHA 2019 | Updated analysis from the HORIZON study of melflufen in RRMM
Paul G. Richardson from the Dana-Farber Cancer Institute, Boston, US, speaks to the Multiple Myeloma Hub about the updated analysis from the HORIZON study of melflufen in RRMM.
Priority Review of melflufen for patients with triple-class refractory MM by FDA
The first-in-class peptide–drug conjugate melphalan flufenamide, also known as melflufen (MF), in combination with dexamethasone is to receive priority review by the...
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