On December 27, 2022 InnoCare Pharma (HKEX: 09969; SSE: 688428) reported the approval of tafasitamab in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT) by the Department of Health, the Hong Kong Special Administrative Region, China (Press release, InnoCare Pharma, DEC 27, 2022, View Source [SID1234625622]).
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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "The Hong Kong approval of tafasitamab and lenalidomide will not only provide access to eligible DLBCL patients in the region, but may also help patient access in the Greater Bay Area soon. Moving forward, we will accelerate the clinical trials of tafasitamab in China in the hopes of meeting more unmet medical needs."
Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, is not approved by the National Medical Products Administration (NMPA) 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 for the treatment of eligible DLBCL patients, under the early access program in Boao Lecheng International Medical Tourism Pilot Zone. As part of this early access program, the first prescription of tafasitamab in combination with lenalidomide was filed in July at the Ruijin Hainan Hospital for an eligible DLBCL patient.
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 autologous stem cell transplantation (ASCT).
About Tafasitamab
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. Continued approval for this indication may be contingent upon verification of clinical benefit 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.
Monjuvi and Minjuvi 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 Europe and Canada. 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.