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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. https://www.businesswire.com/news/home/20200904005123/en. Published Sep 04, 2020. Accessed Sep 07, 2020.