MorphoSys’ off-the-shelf rival to CAR-T approaches finish line with a speedy review
Gilead and Novartis may soon face the first rival to their CAR-T therapies.
The FDA has accepted the BLA for MorphoSys’s tafasitamab, an antibody that targets the same CD-19 antigen that CAR-T therapies do and looked in pivotal studies to be as or more effective. The agency gave it priority review and a PDUFA date of August 30, in-line with the company’s previous projections of a mid-2020 market launch.
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