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MorphoSys : FDA Accepts BLA On Relapsed/refractory Diffuse Large B Cell Lymphoma

MorphoSys AG (MOR) said that the U.S. Food and Drug Administration accepted filing of the company's Biologics License Application or BLA and granted priority review for the company investigational anti-CD19 antibody, tafasitamab, under review in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma.

The priority review designation shortens the FDA review period following the acceptance of the BLA to six months compared to ten months under Standard Review.

The FDA has set a Prescription Drug User Fee Act goal date of August 30, 2020. The FDA has informed MorphoSys that they are not currently planning to hold an advisory committee meeting to discuss the application.

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