CAR-T DLBCL Approval: A Comprehensive Overview
CAR-T DLBCL Approval: A Comprehensive Overview
Diffuse large B-cell lymphoma (DLBCL) is an aggressive form of non-Hodgkin’s lymphoma, accounting for approximately 30% of all newly diagnosed cases. Traditional treatment options, including chemotherapy and stem cell transplantation, have shown limited success in some patients, particularly those with relapsed or refractory disease. However, the advent of chimeric antigen receptor (CAR) T-cell therapy has revolutionized the treatment landscape for DLBCL, offering hope for improved outcomes and prolonged survival.
FDA Approvals for CAR-T Cell Therapies in DLBCL
1. Tisagenlecleucel (Kymriah)
Approved: August 30, 2017
Indication: Treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.
Additional Approval: May 1, 2018
Indication: For the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.
2. Axicabtagene Ciloleucel (Yescarta)
Approved: October 18, 2017
Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL, primary mediastinal large B-cell lymphoma (PMBCL), and transformed follicular lymphoma (TFL).
3. Lisocabtagene Maraleucel (Breyanzi)
Approved: February 5, 2021
Indication: Treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL, high-grade B-cell lymphoma, PMBCL, and follicular lymphoma grade 3B.
Chinese Regulatory Approvals for CAR-T Cell Therapies in DLBCL
1. Axicabtagene Ciloleucel (Yescarta)
Approved: June 22, 2021
Indication: 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) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL), and DLBCL transformed from follicular lymphoma (FL), providing a new treatment option for these patients.
2. Relmacabtagene Autoleucel (Relma-cel)
Approved: September 3, 2021
Indication: For the treatment of adult patients with relapsed or refractory large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, DLBCL transformed from follicular lymphoma, follicular lymphoma grade 3b, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangements (double/triple-hit lymphoma).