Feb 04, 2020: MorphoSys AG announced the initiation of an expanded access program (EAP) in the U.S. for tafasitamab, an investigational anti-CD19 antibody.
The EAP may provide a way to tafasitamab for use in the patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) in combination with lenalidomide.
According to the FDA, expanded access programs – sometimes called “compassionate use” – provide a pathway for the patient to receive an investigational medicine for a serious disease or condition.
They are frequently made available when there are no comparable or satisfactory alternative therapies to treat the disease or conditions; patient enrollment in the clinical trials is not possible; potential patient assistance justifies the potential risk of the treatment and providing the investigational medicine will not interfere with investigational trials that could hold up the medicine’s marketing approval for the treatment indication.
To qualify for the tafasitamab EAP, patients with r/r DLBCL need to assemble the EAP inclusion/exclusion criteria that are associated with the MorphoSys’ L-MIND study.
Treatment of the DLBCL patients in EAP is suggested with tafasitamab in the combination with lenalidomide according to the treatment schedule in L-MIND. The EAP will be available for the limited time while the FDA reviews MorphoSys’ Biologics License Application (BLA) for the tafasitamab.
Tafasitamab: It is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys certified exclusive worldwide rights in order to develop and commercialize tafasitamab from Xencor, Inc.
https://www.morphosys.com/media-investors/media-center/morphosys-initiates-expanded-access-program-for-tafasitamab-in-the-us-0
