{"id":13136,"date":"2020-08-26T07:07:32","date_gmt":"2020-08-26T05:07:32","guid":{"rendered":"http:\/\/wordpress.p545550.webspaceconfig.de\/dr-jean-paul-kress-ist-neuer-ceo-der-morphosys-ag-2\/"},"modified":"2020-08-26T07:20:57","modified_gmt":"2020-08-26T05:20:57","slug":"dr-jean-paul-kress-ist-neuer-ceo-der-morphosys-ag-2","status":"publish","type":"post","link":"https:\/\/www.izb-online.de\/en\/unkategorisiert\/morphosys-breakthrough\/","title":{"rendered":"MorphoSys: Breakthrough in the United States"},"content":{"rendered":"

[vc_row el_class=”gco-magazine-container”][vc_column el_class=”bildspalte”][vc_row_inner][vc_column_inner offset=”vc_col-lg-12 vc_col-md-12″][vc_column_text el_class=”gco-magazine–title”]<\/p>\n

MorphoSys: Breakthrough in the United States<\/h1>\n

[\/vc_column_text][vc_column_text el_class=”gco-magazine–post-date”]August 2020[\/vc_column_text][\/vc_column_inner][\/vc_row_inner][vc_row_inner el_class=”gco-magazine-container–copy”][vc_column_inner][vc_column_text]MorphoSys AG\u00a0 and Incyte announced on the 1st<\/sup> of August 2020 that the U.S. Food and Drug Administration (FDA) has approved Monjuvi\u00ae<\/sup> (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Monjuvi, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, has been approved under accelerated approval by the U.S. FDA based on overall response rate (ORR). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).<\/p>\n

The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy. DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs.<\/p>\n

It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter.3 In the United States each year approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for ASCT.<\/p>\n

\u201cWe are incredibly proud that the FDA has approved Monjuvi in combination with lenalidomide as the first treatment in second-line for patients with relapsed or refractory DLBCL, and we thank all the health care professionals, patients and families involved in our Monjuvi trials,\u201d said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys.<\/p>\n

\u201cThis approval marks an important step in MorphoSys\u2019 transformation into a fully integrated biopharmaceutical company. We remain committed to developing innovative treatments to improve the lives of patients with serious diseases.\u201d Page 2 of 6 \u201cThe FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States,\u201d said Herv\u00e9 Hoppenot, Chief Executive Officer, Incyte.<\/p>\n

\u201cAt Incyte we are committed to advancing patient care and are proud to bring this new and much-needed targeted therapeutic option to appropriate patients and the clinical community.\u201d<\/p>\n

\u201cThe FDA approval of Monjuvi brings a new treatment option to patients in dire need across the United States,\u201d said Professor Gilles Salles, M.D., Chair of the Clinical Hematology Department at the University of Lyon, France, and lead investigator of the L-MIND study. \u201cToday\u2019s FDA decision offers new hope for patients with this aggressive form of DLBCL who progressed during or after first-line therapy.\u201d<\/p>\n

MorphoSys and Incyte will co-commercialize Monjuvi in the United States. Incyte has exclusive commercialization rights outside the United States. MorphoSys and Incyte are committed to supporting patients throughout their treatment journeys and are working together to help lower patient access barriers.[\/vc_column_text][vc_column_text css=”.vc_custom_1583761043671{background-color: #1e73be !important;}” el_class=”redaktionell”][\/vc_column_text][\/vc_column_inner][\/vc_row_inner]\n\n

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