Morphosys/Incyte’s Monjuvi Wins Early US FDA Approval In Second-Line DLBCL

MAb’s CAR-T Like Efficacy Seen Giving Wide Adoption

 
• By Sten Stovall
  
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Monjuvi’s good efficacy and safety profile should enable its broad adoption in the second line DLBCL space and help it compete well against rival CAR-T therapies, analysts said.    

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MorphoSys, Incyte to co-commercialize Monjuvi in the US • Source: Shutterstock

Commercial supplies of Incyte Corporation and MorphoSys AG’s novel CD19-targeting monoclonal antibody will be available in the US by the end of this week after Monjuvi (tafasitamab) won early approval there as a second-line treatment of relapsed or refractory diffuse large B-cell lymphoma. The companies said the patient population size they would be initially targeting there was around 10,000 per annum.

The CD19-directed cytolytic antibody is now indicated as a second-line therapy in combination with Celgene’s Revlimid (lenalidomide) for adult patients...

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