tafasitamab

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Ligands
tafasitamab

GtoPdb Ligand ID: 11131

Synonyms: Minjuvi® | Monjuvi® | MOR-208 | MOR00208 | MOR208 | tafasitamab-cxix | Xmab5574

tafasitamab is an approved drug (FDA (2020), EMA (2021))

Comment: Tafasitamab (MOR208, formerly Xmab®5574) is a humanized Fc-engineered monoclonal antibody directed against CD19 that was developed by MorphoSys [4]. XmAb® antibodies are designed with modifications in their Fc domain (S239D/I332E mutations) that increase binding to Fcγ receptors on immune cells. This optimises the antibody's Fc-mediated effector function (i.e. antibody-dependent cell-mediated cytotoxicity, ADCC) [1,5]. At the beginning ot 2020, MorphoSys and Incyte Corporation entered into a collaboration and license agreement for the global development and commercialization of tafasitamab (MOR208).

No information available.

No information available.

Summary of Clinical Use
The lead indication for use of tafasitamab is relapsed or refractory diffuse large B-cell lymphoma (DBCL; in combination with the multiple myeloma drug lenalidomide) [6]. Regulatory notes: FDA fast track designation for the treatment of relapsed/refractory DLBCL (tafasitamab monotherapy, 2014) EMA orphan drug designation for the indications of CLL/SLL (2014) and DLBCL (2015) FDA breakthrough therapy designation for patients with relapsed/refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplantation (tafasitamab + lenalidomide, 2017) FDA accepted Biologics License Application (BLA) and granted priority review for tafasitamab monotherapy for relapsed/refractory DLBCL (Q1 2020) FDA approval, August 2020: for use in combination with lenalidomide for the treatment of adult patients with DLBCL

Summary of Clinical Use

The lead indication for use of tafasitamab is relapsed or refractory diffuse large B-cell lymphoma (DBCL; in combination with the multiple myeloma drug lenalidomide) [6].

Regulatory notes:
FDA fast track designation for the treatment of relapsed/refractory DLBCL (tafasitamab monotherapy, 2014)
EMA orphan drug designation for the indications of CLL/SLL (2014) and DLBCL (2015)
FDA breakthrough therapy designation for patients with relapsed/refractory DLBCL who are ineligible for high-dose chemotherapy and autologous stem cell transplantation (tafasitamab + lenalidomide, 2017)
FDA accepted Biologics License Application (BLA) and granted priority review for tafasitamab monotherapy for relapsed/refractory DLBCL (Q1 2020)
FDA approval, August 2020: for use in combination with lenalidomide for the treatment of adult patients with DLBCL

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT01685008	Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat Non-Hodgkin´s Lymphoma (NHL)	Phase 2 Interventional	MorphoSys AG		3
NCT02399085	A Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL	Phase 2 Interventional	MorphoSys AG		6
NCT02763319	A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)	Phase 2/Phase 3 Interventional	MorphoSys AG		6