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FDA Approves Label Update for Kite’s Yescarta® for Relapsed/Refractory Primary Central Nervous System Lymphoma

Gilead Sciences, Inc. (GILD)  More Company Research Source: Business Wire
Last gilead sciences, inc. earnings: 4/30 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.gilead.com
– Limitations of Use Removed for Rare and Aggressive Form of non-Hodgkin Lymphoma Based on Manageable Safety Profile with No New Safety Signals Identified – SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL). The updated label reinforces the robust safety data of Yescarta in eligible patients with R/R PCNSL; Yescarta is the only CAR T-cell therapy approved for R/R large B-cell lymphoma to have this Limitations of Use removed.Primary central nervous system lymphoma is a rare and fast-growing lymphoma that originates in the brain, spinal cord, eye, or cerebrospinal fluid. Prognosis for PCNSL remains poor, with a five-year survival rate of approximately 30%. More than half of patien [Read more]
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Stockreport

FDA Approves Label Update for Kite’s Yescarta® for Relapsed/Refractory Primary Central Nervous System Lymphoma

Gilead Sciences, Inc.  (GILD) 
More Company Research Source: Business Wire
Last gilead sciences, inc. earnings: 4/30 04:01 pm Check Earnings Report
US:NASDAQ Investor Relations: investors.gilead.com
– Limitations of Use Removed for Rare and Aggressive Form of non-Hodgkin Lymphoma Based on Manageable Safety Profile with No New Safety Signals Identified – SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) approved an update to the Yescarta® (axicabtagene ciloleucel) prescribing information removing the previous Limitations of Use in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL). The updated label reinforces the robust safety data of Yescarta in eligible patients with R/R PCNSL; Yescarta is the only CAR T-cell therapy approved for R/R large B-cell lymphoma to have this Limitations of Use removed.Primary central nervous system lymphoma is a rare and fast-growing lymphoma that originates in the brain, spinal cord, eye, or cerebrospinal fluid. Prognosis for PCNSL remains poor, with a five-year survival rate of approximately 30%. More than half of patien [Read more]
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