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Monjuvi FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 9, 2020.

FDA Approved: Yes (First approved July 31, 2020)
Brand name: Monjuvi
Generic name: tafasitamab-cxix
Dosage form: for Injection
Company: MorphoSys AG
Treatment for: Diffuse Large B-Cell Lymphoma

Monjuvi (tafasitamab-cxix) is a CD19-directed cytolytic antibody indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Development Timeline for Monjuvi

DateArticle
Aug  1, 2020Approval  FDA Approves Monjuvi (tafasitamab-cxix) in Combination with Lenalidomide for the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
May 14, 2020MorphoSys and Incyte Announce Long-term Follow-up Results from L-MIND Study of Tafasitamab in Patients with r/r DLBCL
Mar  2, 2020FDA Accepts MorphoSys' Biologics License Application (BLA) and Grants Priority Review for Tafasitamab and Lenalidomide for the Treatment of Relapsed/Refractory DLBCL
Dec 30, 2019MorphoSys Announces Submission of Biologics License Application for Tafasitamab in r/r DLBCL to the FDA
Dec 27, 2019First Patient Dosed in Phase 1 Clinical Study of Tafasitamab in Firstline DLBCL

Further information

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