On February 4, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported the launch of an Expanded Access Program (EAP) in the USA for tafasitamab, an anti-CD19 antibody currently under development (Press release, MorphoSys, FEB 4, 2020, View Source [SID1234553831]). Under certain conditions, patients with relapsed or refractory diffuse large B-cell lymphoma (r / r DLBCL) can have access to tafasitamab in combination with lenalidomide via the EAP. Tafasitamab is an active ingredient in development (investigational product), the safety and efficacy of which have not been established.
According to the FDA, programs for expanded access , sometimes referred to as "compassionate use", offer patients an opportunity to gain access to an investigational medication for the treatment of a serious illness. They are often provided when there are no comparable or satisfactory alternative therapies to treat the disease, when the patient cannot be enrolled in a clinical trial, when the potential benefit to the patient justifies the potential treatment risk, and when it is made available of the investigational medicinal product does not affect studies that could support the marketing authorization of the drug for the corresponding treatment indication.
To be eligible for the Tafasitamab EAP, r / r DLBCL patients must meet the EAP inclusion / exclusion criteria that correspond to those in the MorphoSys L-MIND study. Treatment of DLBCL patients under the EAP is recommended with tamasitamab in combination with lenalidomide according to the L-MIND treatment plan. The EAP will be available for a limited time while the FDA is reviewing MorphoSys’s application for a Biologics License Application (BLA) for Tamasitamab. Applications for inclusion in the Tafasitamab EAP must be made by a medical doctor approved in the United States.
The Tafasitamab EAP is from Clinigen Healthcare Ltd. managed. Questions or inquiries regarding the Tafasitamab EAP should be directed to [email protected] .
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About tafasitamab
Tafasitamab is a humanized Fc-modified monoclonal antibody against CD19. In 2010, MorphoSys licensed Xencor, Inc.’s worldwide development and marketing rights for tafasitamab. Tafasitamab has an Fc part modified with the XmAb (R) technology, which is said to lead to a significant increase in antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), and thus to improve a key mechanism of tumor cell killing. MorphoSys is investigating tafasitamab as a therapeutic option for malignant B-cell disorders in a number of ongoing combination studies. An open phase 2 combination study (L-MIND study) examined the safety and efficacy of tafasitamab in combination with lenalidomide in patients with relapsed / refractory DLBCL who were not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT) Question come. Based on preliminary data from L-MIND, the FDA granted therapeutic breakthrough status for tafasitamab plus lenalidomide in this patient population in October 2017.