Tafasitamab

Unassigned

New Medicines

Relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, in combination with lenalidomide

Information

New molecular entity
MorphoSys
MorphoSys

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Approved (Licensed)
Aug 20 · Approved in US in combination with lenalidomide for or treatment of adults with relapsed or refractory DLBCL [6].
May 20 · Filed in EU via centralised procedure [5].
Jan 20 · MorphoSys have partnered with Incyte who will market tafasitamab outside of the USA. [4]
Jan 20 · MorphoSys has submitted a Biologics License Application to the U.S. FDA for tafasitamab, an anti-CD19 antibody, for the treatment of relapsed or refractory diffuse large B cell lymphoma [1].

Category

Humanized Fc-engineered monoclonal antibody directed against CD19
The overall annual incidence of diffuse large B cell lymphoma in Europe is 3.8/100,000 but the incidence increases with age and varies considerably across Europe [2].
Relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) after up to two prior lines of therapy, in combination with lenalidomide
Intravenous

Further information

Yes
To be confirmed

Trial or other data

Jan 20 · PIII ongoing study B-MIND assesses the combination of tafasitamab and bendamustine versus rituximab and bendamustine in r/r DLBCL [1].
Jan 20 · PII trial NCT04150328 is investigating efficacy of tafasitinib plus lenalidomide in R/R DLBCL compared with lenatidomide alone [3].

Evidence based evaluations