Kite’s Tecartus Receives the US FDA’s Approval as the First and Only Car T for Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Shots:

  • The approval was based on a P-I/II ZUMA-3 study assessing Tecartus in adult patients aged ≥18yrs. with ALL whose disease is refractory to or has relapsed following first standard systemic therapy with remission of 12mos. or less, after 2L+ systemic therapy or at least 100 days after ASCT
  • Results: 65% of the evaluable patients achieved CR or CRi @median actual follow-up of 12.3 mos.; mDOR (13.6mos.); Grade 3 or higher CRS (26%); neurologic events (35%); well tolerated
  • Tecartus is the first and only CAR T-cell therapy approved for adults aged ≥18yrs. with ALL. The approval marks Kite’s fourth indication for its cell therapies and first in Leukemia

Click here to­ read full press release/ article | Ref: Gilead | Image: Businesswire

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