CAR-T cell therapy Yescarta wins FDA approval for early-stage lymphoma treatment

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL), accounting for 30%-40% of adult NHL patients in Western countries, and 37.

Gilead Sciences announced today that the FDA has expanded the approval of Yescarta (axicabtagene ciloleucel) to include patients with large B-cell lymphoma (LBCL) who are refractory to first-line chemoimmunotherapy or who have relapsed within 12 months of first-line chemoimmunotherapy

Gilead Chief Executive Christi Shaw noted that the expanded indication will increase the number of lymphoma patients eligible for Yescarta to around 14,000 from the previous 8,000

There are currently 112 authorized centers in the U.

The approval is based on results from the phase III ZUMA-7 study, which Gilead said last year met its primary endpoint of event-free survival (EFS), as well as a key secondary endpoint: overall response rate (ORR)

Recently, the National Comprehensive Cancer Network (NCCN) updated its clinical practice guidelines in oncology to include Yescarta in a category 1 recommendation for LBCL patients with relapsed disease or primary refractory disease within 12 months

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