Press release
Incyte and MorphoSys Announce Positive CHMP Opinion for Tafasitamab in Combination with Lenalidomide for the Treatment of Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- If approved, tafasitamab in combination with lenalidomide would represent an important new therapeutic option for eligible DLBCL patients in the European
About this update from Incyte Corporation
[{"type":"text","content":"\n- If approved, tafasitamab in combination with lenalidomide would represent an important new therapeutic option for eligible DLBCL patients in the European Union \n\n- The positive opinion from the CHMP is based on data from the Phase 2 L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL\n\n WILMINGTON, Del. & PLANEGG, Germany & MUNICH--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the conditional marketing authorization of tafasitamab in combination with lenalidomide, followed by tafasitamab monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT).\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210625005231/en/\n“The CHMP’s positive opinion of tafasitamab is a pivotal step towards addressing an urgent unmet medical need for the 30-40% of patients with relapsed or refractory DLBCL who do not respond to initial therapy or relapse thereafter,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “Following the U.S. FDA’s approval of tafasitamab in July 2020, we eagerly await the European Commission’s decision as we look forward to bringing this new therapy to eligible patients in Europe as soon as possible.”\n\n“Tafasitamab in combination with lenalidomide represents an important new targeted treatment option for patients with relapsed or refractory DLBCL,” said Dr. Malte Peters, Chief Research & Development Officer, MorphoSys. “Patients with relapsed or refractory DLBCL have limited treatment options and often face a poor prognosis. There is an urgent need for effective therapies and if approved, this combination could provide patients in Europe with an important new therapeutic option.”\n\nThe CHMP opinion to recommend the use of tafasitamab is now being reviewed by the European Commission, which has the authority to grant marketing authorization for medicinal products in the European Union (EU). If approved, tafasitamab would be commercialized in the EU under the brand name Minju...