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MorphoSys : Swiss Regulator Accepts Marketing Authorization Application For Tafasitamab

MorphoSys AG (MOR) and Incyte (INCY) said that the Swiss Agency for Therapeutic Products or Swissmedic has accepted the marketing authorization application for tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody.

The marketing authorization application seeks approval for 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), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT).

If approved, Incyte will hold the marketing authorization, and have exclusive commercialization rights for tafasitamab in Switzerland.

Incyte has exclusive commercialization rights for tafasitamab outside the United States.

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