Beijing, June 9, 2022——The 2022 edition of the Chinese Society of Clinical Oncology (CSCO) Lymphoma Diagnosis and Treatment Guidelines (hereinafter referred to as the "Guidelines") was released recently. Tafasitamab in combination with lenalidomide was listed as a Level II recommended treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT). The Guidelines further explain that for relapsed or refractory DLBCL patients, it is recommended to choose treatments or individualized regimens, which do not have cross-resistance with first-line therapy.
In order to further standardize the diagnosis and treatment of lymphoma in China, the CSCO combines both internal and external developments with clinicians' diagnosis and treatment practice to revise the Guidelines regularly, considering the actual situation of Chinese patients while in line with international standards. The Guidelines provide guidance for the diagnosis and treatment of lymphoma patients in China.
“Tafasitamab in combination with lenalidomide was recommended by the CSCO Guidelines for relapsed or refractory diffuse large B-cell lymphoma, demonstrating the recognition of this therapy by CSCO experts. InnoCare is committed to bringing innovative drugs to patients with unmet medical needs in China and the world, " said Dr. Jasmine Cui, co-founder, chairwoman and CEO of InnoCare.
Tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, is not approved by the National Medical Products Administration for any indication in China, except that tafasitamab in combination with lenalidomide has been approved by the Health Commission and Medical Products Administration of Hainan Province, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone for the treatment of eligible relapsed or refractory DLBCL patients.
Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of relapsed or refractory DLBCL patients who are not eligible for ASCT.
Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy.
In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.
Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).
In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Full approval for this indication may be contingent upon results in a confirmatory trial(s).
In Europe, Minjuvi® (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).
Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.
Tafasitamab is not approved for use in China except for in the Boao Lecheng International Medical Tourism Pilot Zone through an early access program.
Minjuvi® and Monjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S. and marketed by Incyte under the brand name Minjuvi® in the EU. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.
XmAb® is a registered trademark of Xencor, Inc.
InnoCare is a commercial stage biopharmaceutical company committed to discovering, developing, and commercializing first-in-class and/or best-in-class drugs for the treatment of cancer and autoimmune diseases. We strategically focus on lymphoma, solid tumors, and autoimmune diseases with high unmet medical needs in China and worldwide. InnoCare has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.
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