Posted by Michael Wonder on 02 Mar 2020
FDA accepts MorphoSys' biologics license application and grants priority review for tafasitamab and lenalidomide for the treatment of relapsed/refractory DLBCL
2 March 2020 - MorphoSys announced today that the U.S. FDA accepted filing of MorphoSys' biologics license application and granted priority review for tafasitamab, the Company's investigational anti-CD19 antibody, under review in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma.
The FDA has set a Prescription Drug User Fee Act goal date of 30 August 2020.
The FDA has informed MorphoSys that they are not currently planning to hold an advisory committee meeting to discuss the application.
