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Kite’s Yescarta (axicabtagene ciloleucel) Receives the US FDA’s Approval for New Label Update in all Approved Indications

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Kite’s Yescarta (axicabtagene ciloleucel) Receives the US FDA’s Approval for New Label Update in all Approved Indications

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  • The update was based on Cohort 6 of (ZUMA-1) study for Yescarta to evaluate the effects of prophylactic use of corticosteroids & earlier treatment with corticosteroids or tocilizumab & prophylactic levetiracetam on the incidence & severity of CRS & neurologic events
  • The results showed no grade ≥3 CRS events in 0% (0/39) over 13% (14/108) in the cohorts 1/2, grade ≥3 neurologic events in 13% (5/39) vs 31% (33/108), 1 patient experienced a late-onset grade 5 event while 68% of patients had no CRS or neurologic events within 72hrs.
  • Yescarta is 1st CAR T-cell therapy to be approved in the US for r/r LBCL & is currently under US FDA & EMA’s review for use as an earlier treatment for 2L r/r LBCL

Ref: Gilead | Image: Industry Pharmacist Organization

Click here to­ read the full press release 

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