Press release
Incyte and MorphoSys Announce the European Commission Approval of Minjuvi® (tafasitamab) in Combination With Lenalidomide for the Treatment of Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- The decision by the European Commission is based on data from the L-MIND study evaluating Minjuvi in combination with lenalidomide as a treatment for
About this update from Incyte Corporation
[{"type":"text","content":"\n- The decision by the European Commission is based on data from the L-MIND study evaluating Minjuvi in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL\n- Minjuvi is a new therapeutic option for eligible DLBCL patients in the European Union (EU), addressing an urgent unmet medical need\n- In Europe, each year approximately 16,000 patients are diagnosed with relapsed or refractory DLBCL1,2,3\n\n WILMINGTON, Del. & PLANEGG, Germany & MUNICH--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) and MorphoSys AG (FSE:MOR; NASDAQ:MOR) today announced that the European Commission (EC) has granted conditional marketing authorization for Minjuvi® (tafasitamab) in combination with lenalidomide, followed by Minjuvi 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 transplant (ASCT). The EC decision follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2021 recommending the conditional marketing authorization of Minjuvi.\n\n“People living with relapsed or refractory DLBCL in the EU, have historically had limited treatment options and a poor prognosis. However, with the EC’s approval of Minjuvi, eligible patients now have a new and much needed treatment option,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “We will now focus our efforts on working with individual countries in Europe to provide people access to this new treatment.”\n\n“The approval of Minjuvi is a crucial milestone for patients with relapsed or refractory DLBCL in Europe,” said Jean-Paul Kress, M.D., Chief Executive Officer, MorphoSys. “DLBCL is the most common type of non-Hodgkin lymphoma in adults and Minjuvi addresses an urgent unmet medical need for the 30-40% of people who do not respond to or relapse, after initial therapy.”\n\nThe conditional approval is based on the results from the L-MIND study evaluating the safety and efficacy of Minjuvi in combination with lenalidomide as a treatment for patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT). The results showed best objective response rate (ORR) of 56.8% (primary endpoint), including a complete response (CR) rate of 39.5% and a par...