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Autologous, CAR-T, CD19

January 31, 2022

FDA Approves an Updated Label for Yescarta to Include Prophylactic Corticosteroids Use

Here is a brief preview of this blast: On Monday, January 31, Gilead (Kite) announced (press release) that the FDA has approved Yescarta’s (CD19 CAR-T) updated prescribing information to include the use of prophylactic corticosteroids across all approved indications. Of note, the label update is based on results from Cohort 6 of the Ph1/2 ZUMA-1 trial in r/r DLBCL. Below, Celltelligence provides insights on Yescarta’s updated US label, while discussing how it could facilitate Yescarta’s administration in the outpatient setting.

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The Celltelligence Team

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The Celltelligence team has combined experience in oncology, including cell therapy, CAR-T, immunology, microbiology, biochemistry, and other various fields in life sciences. Our team members include PhDs, industry veterans, and analysts tuned to The Street – all of whom help to create a more actionable service of delivering cell therapy intelligence.