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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