Hematological Neoplasms

On August 24, 2021, Novartis announced that in the BELINDA Phase III clinical trial, the use of Kymriah (CTL019, tisagenlecleucel) as a second-line treatment for patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL) failed to meet the primary endpoint of event-free survival (EFS) compared to standard of care (SOC).

Axicabtagene ciloleucel (trade name: Yescarta) is a chimeric antigen receptor (CAR) T-cell therapy used to treat certain types of non-Hodgkin’s lymphoma.

The treatment carries a staggering price tag of around $373,000 per patient in the United States.

Before initiating treatment, confirm the patient’s eligibility for this drug, as it is not indicated for the treatment of primary central nervous system lymphoma.

The therapeutic journey of Axicabtagene Ciloleucel begins with the collection of a patient’s T-cells through a process called leukapheresis.

In the case of axicabtagene ciloleucel, the T-cells are engineered to target and eliminate cells that express a protein called CD19, which is found on the surface of B-cells, including the cancerous B-cells in follicular lymphoma.

On December 21, 2023, Kite, a Gilead company, announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtagene ciloleucel), incorporating the pivotal Phase 3 ZUMA-7 study’s overall survival (OS) analysis.

On March 5, 2021, the U.S. Food and Drug Administration (FDA) approved Axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

On September 28, 2022, the European Commission (EC) approved the CD19 CAR-T cell therapy Yescarta (axicabtagene ciloleucel) for a new indication: the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) after one line of systemic therapy.

On June 28, 2022, local time, Gilead’s cell therapy company Kite Pharma announced that the European Commission (EC) has approved its CAR-T cell therapy Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.