MorphoSys Reports Submission of Tafasitamab's BLA to the US FDA to Treat Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)
Shots:
- The BLA submission is based on L-MIND P-II trial data results assessing Tafasitamab + lenalidomide in patients with r/r DLBCL and retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received Tafasitamab + lenalidomide vs lenalidomide monothx
- Re-MIND has met its 1EPs and has shown improved ORR of the tafasitamab/lenalidomide combination vs lenalidomide monothx. In Oct 2017- Tafasitamab + Lenalidomide received the US FDA’s Breakthrough Therapy Designation
- Tafasitamab (MOR208) is an investigational Fc-engineered mAb directed against CD19 and is being evaluated in B-MIND P-III trial in combination with bendamustine vs rituximab + bendamustine in patients with r/r DLBCL
Click here to read full press release/ article | Ref: MorphoSys | Image: Behance
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