Good article explaining CAR-T and the status of three CAR-T submissions to the FDA.
There is a great April 7, 2017 4:24 minute video on CAR-T therapy at the below website. The takeaways of interest to me were that the patient population was very sick, the response rate was much higher than other therapies, the side effects are known and controllable, and most important to me (at the end of the video) was that the CR duration was durable.
This video reviews results of the ZUMA-1 trial, which tested the CAR T-cell therapy axicabtagene ciloleucel in patients with advanced non-Hodgkin lymphoma.
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/