Gilead’s Kite announces new label update for Yescarta
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Kite, a subsidiary of Gilead (NASDAQ:GILD) announced that the FDA approved an update to the prescribing information of its CAR T-cell therapy Yescarta (axicabtagene ciloleucel), allowing the use of corticosteroids across all its indications to manage the adverse events.

The regulatory clearance supporting the use of prophylactic use of corticosteroids was based on the results of a new safety management cohort (Cohort 6) of the pivotal ZUMA-1 study, where there were no Grade â¥3 events of cytokine release syndrome (CRS) [0% (0/39)].
In comparison, CRS events in the pivotal Cohorts 1/2 stood at 13% (14/108). The additional data suggest that 68% of patients had no CRS or neurologic events within 72 hours following Yescarta infusion. 
The CD19-directed autologous T cell immunotherapy is currently approved in the U.S. for certain patients with large B-cell lymphoma and follicular lymphoma.
In the first nine months of 2021, Yescarta generated $300M in revenue for Gilead (GILD) in the U.S. with ~6% YoY growth.