MorphoSys AG / Key word(s): Regulatory Approval
MorphoSys AG: Ad hoc: FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
01-Aug-2020 / 01:35 CET/CEST
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Ad hoc release according to article 17 para. 1 MAR
Ad hoc: FDA Approves Monjuvi(R) (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Adult Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) today announces that the U.S. Food and Drug Administration (FDA) has approved Monjuvi(R) (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). Monjuvi, a humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, has been approved under accelerated approval by the U.S. FDA based on overall response rate (ORR). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA decision represents the first approval of a second-line treatment for adult patients who progressed during or after first-line therapy.
The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter, single arm trial of Monjuvi in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL. The FDA previously granted Fast Track and Breakthrough Therapy Designation for this combination in relapsed or refractory DLBCL, and the Biologics License Application (BLA) for Monjuviwas granted Priority Review and approved under the FDA’s Accelerated Approval program.
Monjuvi is expected to be commercially available in the United States shortly. MorphoSys and its partner Incyte (Nasdaq: INCY) will co-commercialize Monjuvi in the United States. Incyte has exclusive commercialization rights outside the United States.
END OF AD HOC RELEASE
Information and Explanation of the Issuer to this News:
MorphoSys Forward-Looking Statements
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01-Aug-2020 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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