NMPA Accepts BLA for Tafasitamab Plus Lenalidomide in Relapsed or Refractory DLBCL

The China National Medical Products Administration (NMPA) has accepted a biologics license application (BLA) for tafasitamab in combination with lenalidomide to treat relapsed or refractory DLBCL in adults ineligible for autologous hematopoietic stem cell transplant (HSCT).

Tafasitamab is a humanized, Fc-modified monoclonal antibody that targets the CD19 antigen. InnoCare Pharma performs development and the exclusive commercialization of this immunotherapy agent in greater China.

In the United States, the combination of this agent with lenalidomide to treat relapsed or refractory DLBCL in adults ineligible for autologous HSCT has received accelerated approval by the FDA. The European Medicines Agency has granted conditional marketing authorization for the use of this doublet followed by tafasitamab monotherapy in this setting.