Hematological Neoplasms

Axicabtagene ciloleucel (axi-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy that received FDA approval in 2017 for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and transformed follicular lymphoma (TFL).

Axicabtagene Ciloleucel is a type of chimeric antigen receptor (CAR) T-cell therapy, a cutting-edge form of immunotherapy.

In early April 2024, the U.S. Food and Drug Administration (FDA) approved an updated prescribing information for Yescarta (Axicabtagene Ciloleucel) to include overall survival (OS) data in adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after first-line therapy containing Rituximab Injection and Anthracyclines.

On October 17, 2022, exciting news arrived from the European Commission (EC). Based on data from the ZUMA-7 study, the EC officially approved a new indication for Yescarta® for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) who are refractory to or relapse within 12 months after first-line chemoimmunotherapy.

On April 1, 2022, Kite, a U.S. company, announced that the U.S. Food and Drug Administration (FDA) has approved its CAR-T cell therapy drug Yescarta (Axicabtagene Ciloleucel) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after one prior line of systemic therapy, including patients who have progressed within 12 months of first-line chemoimmunotherapy.

Yescarta (Axicabtagene ciloleucel, axi-cel) is an autologous anti-CD19 chimeric antigen receptor (CAR)-T cell therapy approved for relapsed/refractory (R/R) follicular lymphoma (FL).

The approval history of Yescarta is a medical innovation story that spans across borders.

This ongoing phase II study enrolled patients with R/R MCL who had received ≥1 prior line of treatment.

Follicular lymphoma (FL) is the most common indolent lymphoma and the second most common type of lymphoma globally, accounting for approximately 22% of newly diagnosed lymphomas worldwide. Currently, there is no standard treatment for relapsed/refractory FL.

On May 4, 2022 (Basel), Novartis announced that the European Commission has expanded the approval of Kymriah (tisagenlecleucel) to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

On December 12, 2021, at the 63rd American Society of Hematology (ASH) Annual Meeting, Novartis presented subgroup analysis data from the Phase 2 ELARA study with a median follow-up of 17 months.