Hematological Neoplasms

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.

On October 18, 2017, the U.S. FDA approved the CAR-T cell therapy Yescarta for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including patients with diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

On May 27, 2022, Novartis announced on its official website that the U.S. FDA has granted accelerated approval for a new indication of its CAR-T cell therapy Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy.

On May 2, 2018, the U.S. FDA approved Novartis’ CAR-T cell therapy drug Kymriah (Tisagenlecleucel, CTL019) for a second indication, to treat adult patients with relapsed or refractory large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, including the most common form of non-Hodgkin lymphoma—diffuse large B-cell lymphoma (DLBCL)—as well as high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma (FL).

Although autologous anti-CD19 CAR-T cell therapy is highly effective in treating large B-cell lymphomas, less than half of r/rDLBCL patients experience a response duration exceeding 1 year.

As an emerging cancer treatment, chimeric antigen receptor T-cell (CAR-T) therapy has achieved significant therapeutic effects in the treatment of lymphoma.