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.