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Tecartus Approval History

FDA Approved: Yes (First approved July 24, 2020)
Brand name: Tecartus
Generic name: brexucabtagene autoleucel
Dosage form: Suspension for Intravenous Infusion
Previous Name: KTE-X19
Company: Kite, a Gilead Company
Treatment for: Mantle Cell Lymphoma

Tecartus (brexucabtagene autoleucel) is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

Development History and FDA Approval Process for Tecartus

Jul 24, 2020Approval FDA Approves Tecartus (brexucabtagene autoleucel) as the First and Only CAR T Treatment for Relapsed or Refractory Mantle Cell Lymphoma
Feb 10, 2020U.S. FDA Grants Priority Review for Kite’s KTE-X19 Biologics License Application (BLA) in Relapsed or Refractory Mantle Cell Lymphoma
Dec 11, 2019Kite Submits Biologics License Application to U.S. Food and Drug Administration for Company’s Second CAR T Cell Therapy KTE-X19
Jun  1, 2019Kite Announces End of Phase 1 ZUMA-3 Results for KTE-X19 in Adult Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia

Further information

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