Gilead Sciences Inc. subsidiary Kite Pharma Inc. will file a biologic license application (BLA) for KTE-X19 with the US Food and Drug Administration by the end of this year, offering a second CD19-targeting chimeric antigen receptor T-cell (CAR-T) therapy for hard-to-treat lymphoma patients as one new competitor edges closer to launch and several other companies advance new technologies.
Kite Readies A Second CAR-T For Filing As CD19 Competition Grows
The Gilead subsidiary presented updated data at ASH for its first CD19-targeting CAR-T Yescarta and pivotal results for KTE-X19, which it plans to submit for US FDA approval in mantle cell lymphoma this year.
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