It will be the first tafasitamab-based treatment for diffuse large B-cell lymphoma (DLBCL) in China if successful.
InnoCare Pharma (Chinese: 诺诚健华,09969) announced yesterday that Tafasitamab and Lenalidomide Combo has been granted the approval for Phase II clinical trial by the national medical products administration of China (NMPA).
A single-arm, open-label and multi-arm trial will be conducted to evaluate the safety and efficacy of Tafasitamab and Lenalidomide Combo in treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) among adult patients who are not elibigle for autologous stem cell transplantation.
Tafasitamab is a humanized Fc-modified monoclonal antibody directly against CD19. Tafasitamab and Lenalidomide Combo has been granted the conditional approval for treating adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplantation by the US Food and Drug Administratin (FDA) and the European Medicines Agency (EMA). However, it has not been approved for any indication by NMPA.
InnoCare Pharma signed a cooperation and licensing agreement with Incyte in August, 2021 for the development and exclusive commercialization of tafastitamab in treating hematoma and solid tumors in greater China.