August 27, 2018
Yescarta® (Axicabtagene Ciloleucel) Receives European Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL, After Two or More Lines of Systemic Therapy
-- New Option for Adult Patients in
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Axicabtagene ciloleucel is a chimeric antigen receptor T cell (CAR T)
therapy, which harnesses a patient’s own immune system to fight certain
types of blood cancer. The cell therapy has been proven to induce
complete response (no detectable cancer) in a proportion of patients
with relapsed or refractory DLBCL and PMBCL, which are aggressive forms
of non-Hodgkin lymphoma (
“Axicabtagene ciloleucel is a new and exciting way of treating cancer
that offers a new option to patients with DLBCL and PMBCL in Europe,”
The Marketing Authorization Application (MAA) is supported by data from
the ZUMA-1 trial of axicabtagene ciloleucel in adult patients with
Axicabtagene ciloleucel may cause side effects that are severe or life threatening, such as cytokine release syndrome (CRS) or neurological toxicities. In ZUMA-1, 12 percent of patients experienced Grade 3 or higher CRS and 31 percent experienced Grade 3 or higher neurologic toxicities. Overall 98 percent of patients recovered from CRS and/or neurologic adverse reactions. Treatment algorithms have been developed to manage some of the symptoms associated with both CRS and neurologic adverse reactions experienced by patients on axicabtagene ciloleucel.
The most common Grade 3 or higher adverse reactions include encephalopathy, unspecified pathogen infection, CRS, bacterial infection, aphasia, viral infection, delirium, hypotension and hypertension.
For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management) please refer to the EU Summary of Product Characteristics (SmPC).
“We are proud to be leading this frontier of cancer innovation that is
bringing novel, personalized therapy to people living with these blood
Axicabtagene ciloleucel was approved by the
This press release includes forward-looking statements, within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
that physicians may not see the benefits of prescribing axicabtagene
ciloleucel for the treatment of DLBCL and PMBCL and the possibility of
unfavorable results from additional clinical trials involving
axicabtagene ciloleucel. All statements other than statements of
historical fact are statements that could be deemed forward-looking
statements. These risks, uncertainties and other factors could cause
actual results to differ materially from those referred to in the
forward-looking statements. The reader is cautioned not to rely on these
forward-looking statements. These and other risks are described in
detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended
Full European Summary of Product Characteristics for Yescarta® is available from the EMA website at www.ema.europa.eu.
Yescarta is a registered trademark of
For more information on Kite, please visit the company’s website at www.kitepharma.com.Learn more about Gilead at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180827005248/en/
Gilead Sciences, Inc.
Sung Lee, +1-650-524-7792
Nathan Kaiser, +1-650-522-1853
Sarah Swift, +44 (208) 587-2618