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Saturday, August 1, 2020

FDA OKs Incyte/Morphosys’ tafasitamab for treatment-resistant lymphoma

Morphosys AG (NASDAQ:MOR) and collaboration partner/licensee Incyte (NASDAQ:INCY) announce the FDA nod for Monjuvi (tafasitamab-cxix), combined with lenalidomide, for the treatment of adult patients with relapsed/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.
Under the terms of their January 2020 agreement, the companies will co-commercialize the the humanized Fc-modified cytolytic anti-CD19 monoclonal antibody in the U.S. while INCY will exclusively commercialize ex-U.S.
U.S. commercial launch will commence shortly.

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