The Lymphoma Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

The FDA accepts a supplemental biologics license application for axicabtagene ciloleucel in patients with R/R FL or MZL

Sep 8, 2020

On September 4, 2020, the U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) for axicabtagene ciloleucel (axi-cel) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL) and marginal zone lymphoma (MZL) after two or more prior lines of systemic therapy. 1

Axi-cel, an anti-CD19 autologous chimeric antigen receptor (CAR) T-cell product, is already approved for the treatment of adult patients with R/R large B-cell lymphoma (LBCL) after ≥ 2 lines of systemic therapy, and previously the FDA granted breakthrough therapy designation to axi-cel for R/R FL or MZL. In case of approval, axi-cel would be the first commercial CAR T-cell therapy approved for R/R FL or MZL.

The sBLA submission was based on data from the ongoing single-arm, multicenter, open-label, phase II ZUMA-5 trial ( NCT03105336). Interim results of this study were reported at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. Axi-cel showed high rates of durable responses and a manageable safety profile (read the full article on the ZUMA-5 study, here).

Axi-cel could represent a valid treatment option for patients with late line R/R FL and MZL who have exhausted other approved treatment options.

  1. Business Wire. Kite submits supplemental biologics license application to U.S. Food and Drug Administration for Yescarta® in relapsed or refractory indolent non-Hodgkin lymphomas. Published Sep 04, 2020. Accessed Sep 07, 2020.