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FDA Approves Oncopeptides´ PEPAXTO® (melphalan flufenamide) for Patients with Triple-Class Refractory Multiple Myeloma


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WALTHAM, Mass., March 1, 2021 /PRNewswire/ 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 the U.S. Food and Drug Administration (FDA) has approved PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen, 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. This indication has been granted under accelerated approval based upon the HORIZON trial. PEPAXTO is the first anticancer peptide-drug conjugate approved in multiple myeloma. ....

United States , Los Altos , Dana Farber Cancer Institute , Marty Duvall , Sarah Connors , Linda Holmstr , Jakob Lindberg , Paulg Richardson , Us Communications , Jerome Lipper Multiple Myeloma Center , Oncopeptides Inc , Drug Administration , Clinical Research , Clinical Program Leader , Nasdaq Stockholm , Dana Farber Cancer , Overall Response Rate , Median Duration , Chief Scientific Officer , Multiple Myeloma , Chief Executive Officer , New Drug Application , Triple Class Refractory , Director Investor Relations , Oncopeptides Ab , ஒன்றுபட்டது மாநிலங்களில் ,

FDA approves Oncopeptides' PEPAXTO ( melphalan flufenamide) for patients with relapsed or refractory multiple myeloma


FDA approves Oncopeptides PEPAXTO ( melphalan flufenamide) for patients with relapsed or refractory multiple myeloma
STOCKHOLM, Feb. 26, 2021 /PRNewswire/ 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 the U.S. Food and Drug Administration, FDA, has approved PEPAXTO
(melphalan flufenamide, also known as melflufen), 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. ....

United States , United Kingdom , Martyj Duvall , Anders Martin , Ola Landgren , Rolf Gulliksen , Klaas Bakker , Linda Holmstr , Jakob Lindberg , Leader Of Experimental Therapeutics Program , Myeloma Program , Sylvester Comprehensive Cancer Center , Drug Administration , Global Head Of Corporate Communications , University Of Miami Health System In , Division Of Hematology , Nasdaq Stockholm , Chief Executive Officer , New Drug Application , Chief Scientific Officer , Professor Ola Landgren , Experimental Therapeutics Program , Miami Health System , Overall Response Rate , Median Duration , Extra Medullary Disease ,