Kite Submitted 1st Commercial CAR-T to FDA for Approval on March 31, 2017

Kite Pharma released more data this morning that it hopes will lead this year to the first commercial approval of a cutting-edge cancer treatment known as CAR-T therapy.

The Santa Monica, CA, firm will soon ask [in 2017] the FDA for approval to use its CAR-T therapy, known as axicabtagene ciloleucel, to treat patients with desperate cases of non-Hodgkin lymphoma, or NHL. An FDA decision could come before year’s end. Kite (NASDAQ: KITE) CEO Arie Belldegrun used rather lofty rhetoric to describe the results. “Few have been granted the opportunity to potentially change the course of medical history,” he said on a conference call with analysts Tuesday morning. “We at Kite believe we’ve been provided such an opportunity. Today is a defining moment of CAR-T therapy as we announce exceptional outcomes with just a single infusion.”

Full story at: http://www.xconomy.com/national/2017/02/28/with-eye-on-fda-kite-says-car-t-for-lymphoma-holds-up-after-6-months/#

UPDATE: Kite submitted CAR-T (axicabtagene ciloleucel) for FDA approval on March 31, 2017. Source: https://www.smarteranalyst.com/2017/03/31/kite-pharma-inc-kite-announces-submission-biologics-license-application-fda-axicabtagene-ciloleucel/

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