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U S FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy

U S FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy
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FDA Approves Oncopeptides´ PEPAXTO® (melphalan flufenamide) for Patients with Triple-Class Refractory Multiple Myeloma

Share this article Share this article 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.

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.

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
prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.

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