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

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

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.    

Lymphoma
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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