Incyte - MorphoSys's Diffuse Large B-Cell Lymphoma Drug Wins European Approval

Incyte - MorphoSys's Diffuse Large B-Cell Lymphoma Drug Wins European Approval
  • The European Commission (EC) has granted conditional approval to Incyte Corporation INCYMorphoSys AG's MOR Minjuvi (tafasitamab) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
  • The approval covers Minjuvi combined with lenalidomide, followed by Minjuvi monotherapy, for DLBCL patients who are not eligible for autologous stem cell transplant (ASCT). 
  • The conditional approval is based on the results from the L-MIND study that showed the best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a partial response rate (PR) of 17.3%. 
  • Incyte has exclusive commercialization rights to tafasitamab outside the U.S. 
  • Related content: Benzinga's Full FDA Calendar
  • Price Action: MOR shares traded 1.27% higher at $14.31 premarket Friday, and Incy shares closed 0.81% lower at $75.15 on Thursday.

Posted In: BriefsDiffuse Large B-Cell LyphomaBiotechNewsHealth CareSmall CapFDAGeneral