With this approval, Kite's median turnaround time (TAT) in the
Median TAT is defined as time from leukapheresis, when a patient's T cells are collected, to product release; manufacturing is a key step within this process to prepare a patient's cells for a one-time cell therapy infusion customized for each patient.
'For patients with relapsed or refractory large B-cell lymphoma, every day matters as the patient's disease can be aggressive and worsen rapidly,' said
CAR T-cell therapies are one-time treatments individually made starting from a patient's own white blood cells, called T-cells. The cells are removed through leukapheresis and sent to Kite's specialized manufacturing facilities where they are modified with a Chimeric Antigen Receptor (CAR). Once an individual therapy is created for a patient, the cells are carefully checked, preserved, packed and sent back to the hospital to be infused back into the patient. The CAR T-cell therapy process is a continuous one, from leukapheresis to the delivery of the final product, so the timing and scheduling of this process are critical to the supply.
Industry experts agree that shortening the time to Yescarta product release and delivery can allow healthcare providers at Kite Authorized Treatment Centers to better support their patients.
'Since the first CAR T-cell therapies were approved more than five years ago and the volume of patients treated has grown from hundreds to several thousand patients each year, we have significantly strengthened our knowledge and understanding of cell therapy delivery,' said
More than 17,700 patients have been treated with Kite's CAR T-cell therapies through these ATCs across the globe. Kite has taken a unique approach to scaling the technology of cell therapy, combining capacity, speed, and reliability and the largest in-house cell therapy manufacturing network in the world to rapidly deliver products to these authorized treatment centers.
'Given that each cell therapy batch is unique to each patient, manufacturing is central to how we deliver our therapies, and quality, reliability, and speed are critical,' said
Kite has continued to increase its manufacturing network capacity to meet growing demand, ensuring scheduling availability to meet the needs of physicians and their patients.
About Yescarta (Axicabtagene Ciloleucel)
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.
Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.
Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial(s).
About Kite
Kite, a
About
Forward-Looking Statements
This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead and Kite's ability to increase its CAR T-cell therapy manufacturing capacity, timely manufacture and deliver such therapies (or otherwise reduce the time to manufacture such therapies), or produce an amount of supply sufficient to satisfy demand for such therapies; the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta; the risk that CAR T-cell therapy will not be broadly accepted by physicians, patients, hospitals, cancer treatment centers, payers and others in the medical community and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended
Contact:
Email: investorrelations@gilead.com
Email: msmith@gilead.com
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