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MorphoSys Announce Validation Of EMA Application For Tafasitamab

MorphoSys AG (MOR) and Incyte (INCY) announced the validation of the European
Marketing Authorization Application for tafasitamab, an anti-CD19 antibody.

The company said the application seeks approval 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 (r/r DLBCL), including DLBCL arising from low grade lymphoma, who are not candidates for autologous stem cell transplantation (ASCT).

The validation of the MAA by the European Medicines Agency confirms that the submission is ready to enter the formal review process.

The MAA, submitted by MorphoSys, is based on data from the L-MIND study evaluating tafasitamab in combination with lenalidomide as a treatment for patients with r/r DLBCL; and is supported by the Re-MIND study, an observational retrospective study in r/r DLBCL.

If approved, Incyte will hold the marketing authorization, and has exclusive commercialization rights for tafasitamab outside of the United States, including Europe.

DLBCL is the most common type of non-Hodgkin lymphoma in adults worldwide -comprising 40% of all cases1. It is an aggressive disease affecting the -cells of the immune system with 30-40% of patients who do not respond to initial therapy or relapse thereafter, leading to a high medical need for new, effective therapies.

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