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)

– First FDA approval of a second-line treatment for adult patients with relapsed or refractory DLBCL, helping fill a high unmet medical need
– FDA granted Monjuvi Fast Track, Breakthrough Therapy and Priority Review designations
– MorphoSys and Incyte will co-commercialize Monjuvi in the United States
– Joint analyst and investor conference call and webcast scheduled for Monday, August 3, 2020 at 8:00 a.m. EDT / 2:00 p.m. CEST

PLANEGG & MUNICH, GERMANY & WILMINGTON, DE / ACCESSWIRE / July 31, 2020 / MorphoSys AG (FSE:MOR)(Prime Standard Segment; MDAX & TecDAX)(NASDAQ:MOR) and Incyte (INCY) today announced 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).1 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.

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide2, characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs. It is an aggressive disease with about one in three patients not responding to initial therapy or relapsing thereafter.3 In the United States each year approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for ASCT.4,5,6

“We are incredibly proud that the FDA has approved Monjuvi in combination with lenalidomide as the first treatment in second-line for patients with relapsed or refractory DLBCL, and we thank all the health care professionals, patients and families involved in our Monjuvi trials,” said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. “This approval marks an important step in MorphoSys’ transformation into a fully integrated biopharmaceutical company. We remain committed to developing innovative treatments to improve the lives of patients with serious diseases.”

“The FDA approval of Monjuvi in combination with lenalidomide helps address an urgent unmet medical need for patients with relapsed or refractory DLBCL in the United States,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “At Incyte we are committed to advancing patient care and are proud to bring this new and much-needed targeted therapeutic option to appropriate patients and the clinical community.”

“The FDA approval of Monjuvi brings a new treatment option to patients in dire need across the United States,” said Professor Gilles Salles, M.D., Chair of the Clinical Hematology Department at the University of Lyon, France, and lead investigator of the L-MIND study. “Today’s FDA decision offers new hope for patients with this aggressive form of DLBCL 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. Results from the study showed a