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The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.
The European Commission (EC) granted conditional marketing authorization on Aug. 26, 2021, to Incyte and MorphoSys for Minjuvi (tafasitamab), a humanized fragment crystallizable region (Fc)-modified cytolytic CD19-targeting monoclonal antibody (mAb), for use in combination with lenalidomide, followed by Minjuvi monotherapy, to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The indication is specifically for DLBCL patients who are not eligible for autologous stem cell transplant (ASCT).
The EC’s decision follows a positive opinion granted by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2021. The conditional approval is based on results from a Phase II study whose results showed best objective response rate of 56.8% (a primary endpoint of the study). The results also showed a complete response rate of 39.5% and a partial response rate of 17.3%. Minjuvi combined with lenalidomide demonstrated a clinically meaningful response and had manageable side effects, according to a company press release.
Under an agreement, Incyte and MorphoSys share global development rights to tafasitamab. Incyte has exclusive commercialization rights to the mAb outside the United States. Tafasitamab is co-marketed by Incyte and MorphoSys under the Monjuvi brand name in the US and is marketed by Incyte under the brand name Minjuvi in the European Union.
Monjuvi in the US is approved in combination with lenalidomide to treat adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT.
“People living with relapsed or refractory DLBCL in the EU [European Union], 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, CEO, Incyte, in the press release. “We will now focus our efforts on working with individual countries in Europe to provide people access to this new treatment.”
“The approval of Minjuvi is a crucial milestone for patients with relapsed or refractory DLBCL in Europe,” said Jean-Paul Kress, CEO, MorphoSys, in the press release. “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.”