What are Kite FDA Approved CAR-T Cell Therapies
What are Kite FDA Approved CAR-T Cell Therapies
Introduction to Kite Company
Kite, a pioneering biotechnology company, has firmly established itself as a leader in the development of novel cancer immunotherapies. Founded in 2009, Kite has dedicated its resources to advancing cellular therapies, particularly in the realm of T-cell therapies for cancer treatment. In 2017, Kite was acquired by Gilead Sciences, significantly enhancing its research capabilities and global reach. Today, Kite continues to push the boundaries of cancer treatment with its focus on chimeric antigen receptor T-cell (CAR-T) therapies and T-cell receptor (TCR) therapies.
FDA-Approved CAR-T Therapies by Kite
Kite’s groundbreaking CAR-T therapies have garnered significant attention from the medical community due to their remarkable efficacy in treating various blood cancers. Currently, two CAR-T products from Kite have been approved by the Food and Drug Administration (FDA) in the United States: Yescarta (Axicabtagene ciloleucel) and Tecartus (Brexucabtagene autoleucel).
1. Yescarta (Axicabtagene ciloleucel)
First Approval: October 18, 2017
Indication: Yescarta was initially approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy. It is the first CAR-T therapy approved for non-Hodgkin’s lymphoma (NHL) and the second CAR-T therapy to be approved globally.
Expanded Indications:
March 6, 2021: Yescarta received an additional FDA approval for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.
April 2022: The FDA granted Yescarta approval as a frontline therapy for adult patients with LBCL who are refractory to, or have relapsed within 12 months of, first-line chemoimmunotherapy. This marks a significant milestone as the first CAR-T therapy approved as a second-line treatment for LBCL.
Mechanism of Action: Yescarta works by genetically modifying a patient’s T-cells to express a chimeric antigen receptor (CAR) that targets CD19, a protein found on the surface of B-cells and several types of blood cancer cells. These modified T-cells are infused back into the patient, enabling them to recognize and eliminate CD19-positive cancer cells.
2. Tecartus (Brexucabtagene autoleucel)
First Approval: July 24, 2020
Indication: Tecartus was approved by the FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior therapies, including a Bruton tyrosine kinase (BTK) inhibitor. It is the first CAR-T therapy approved for MCL.
Expanded Indications:
October 2021: Tecartus received a second FDA approval for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL). This approval makes Tecartus the first CAR-T therapy approved for ALL in adults.
September 6, 2022: The European Commission (EC) approved Tecartus for the treatment of adult patients aged 26 and older with relapsed or refractory B-ALL, further expanding its global reach.
Mechanism of Action: Similar to Yescarta, Tecartus involves genetically modifying a patient’s T-cells to express a CAR that targets CD19. These CAR-T cells are then infused back into the patient, enabling them to specifically attack CD19-positive cancer cells, including those in MCL and B-ALL.
Conclusion
Kite’s FDA-approved CAR-T therapies, Yescarta and Tecartus, have revolutionized the treatment landscape for certain types of blood cancers. By harnessing the power of the patient’s own immune system, these therapies offer hope to patients who have exhausted other treatment options. As research continues, we can expect to see even more advancements in the field of CAR-T therapy, further expanding the range of cancers that can be effectively treated.