Overview of Axicabtagene Ciloleucel Approval

Overview of Axicabtagene Ciloleucel Approval

What is Axicabtagene Ciloleucel

Axicabtagene Ciloleucel is a type of chimeric antigen receptor (CAR) T-cell therapy, a cutting-edge form of immunotherapy. It harnesses the power of the body’s own immune system to fight cancer cells. In this treatment, a patient’s T-cells (a type of immune cell) are extracted and genetically engineered to express a specific receptor that targets and binds to a protein called CD19, which is found on the surface of certain cancer cells, particularly in certain types of lymphoma and leukemia.

Overview of Axicabtagene Ciloreucel’s First Approval

U.S. Pioneering Approval

The revolutionary journey of Axicabtagene Ciloleucel began in the United States, where it was pioneered and first approved. On October 18, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Axicabtagene Ciloleucel, marketed as Yescarta, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

European Union’s Embrace

Following the U.S. approval, the European Union swiftly recognized the potential of this groundbreaking therapy. On August 27, 2018, the European Medicines Agency (EMA) approved Axicabtagene Ciloleucel, under the brand name Yescarta, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy.

Japan’s Trailblazing Step

Japan became a trailblazer in the field of CAR-T cell therapy when it approved Axicabtagene Ciloleucel on March 25, 2019. The approval granted by the Japanese Ministry of Health, Labour and Welfare (MHLW) was for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL transformed from follicular lymphoma.

China’s Embrace of Innovation

On November 11, 2022, the National Medical Products Administration (NMPA) of China granted conditional approval for Axicabtagene Ciloleucel, under the brand name Yescarta, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.

Overview of Axicabtagene Ciloreucel’s Approval for Expanded Indications

United States: Expanded Approval

In March 2022, the U.S. Food and Drug Administration (FDA) granted an expanded approval for Axicabtagene Ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This approval was based on the results of the ZUMA-5 clinical trial, which demonstrated the efficacy and safety of Axicabtagene Ciloleucel in this patient population.

European Union: Broadened Indications

Following the initial approval in 2018, the European Medicines Agency (EMA) further broadened the indications for Axicabtagene Ciloleucel (Yescarta) in April 2022. The updated approval included the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy.

Japan: Additional Approval for Follicular Lymphoma

In January 2023, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted an additional approval for Axicabtagene Ciloleucel (Yescarta) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after three or more lines of systemic therapy. This expanded the therapeutic options available for Japanese patients with this type of lymphoma.

Canada: Comprehensive Approval

Health Canada approved Axicabtagene Ciloleucel (Yescarta) in February 2019 for the treatment of 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), primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL). In May 2022, the indications were expanded to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

These expanded approvals and indications demonstrate the ongoing research and clinical evidence supporting the use of Axicabtagene Ciloleucel in various types of lymphoma, providing hope and treatment options for patients worldwide.