Kite's Tecartus (Brexucabtagene Autoleucel) Authorized by Health Canada for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
The TECARTUS Product Monograph has a?SERIOUS WARNINGS AND PRECAUTIONS BOX?regarding the risks of:
- Cytokine Release Syndrome (CRS),?including life-threatening reactions, occurred in patients receiving TECARTUS. Do not administer TECARTUS if a patient has active uncontrolled infection or inflammatory disorders, active graft-versus-host disease (GVHD) or unresolved serious adverse reactions from prior therapies. Monitor for CRS after treatment with TECARTUS. Provide supportive care, tocilizumab, or tocilizumab and corticosteroids, as needed.xiii
- Neurologic adverse reactions, including life-threatening reactions, occurred in patients receiving TECARTUS, including concurrently with CRS or independently of CRS. Monitor for neurologic adverse reactions after treatment with TECARTUS. Provide supportive care, tocilizumab (if with concurrent CRS), or corticosteroids, as needed.xiv
Kite, a Gilead Company, is a global biopharmaceutical company based in?Santa Monica, California, with commercial manufacturing operations in?North America?and?Europe. Kite's singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company.? For more information on Kite, please visit?www.kitepharma.com. About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in?Foster City, California. Gilead Sciences Canada, Inc. is the Canadian affiliate of Gilead Sciences, Inc., and was established in?Mississauga, Ontario, in 2006. For more information on Gilead Sciences, please visit the company's website at?http://www.gilead.ca/. Forward-Looking Statement
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 Kite may not realize the potential benefits of Tecartus therapy and the possibility of unfavorable results from other ongoing and additional clinical studies involving Tecartus?. 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?June 30, 2021?as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements. ?TECARTUS, XLP, KITE, the KITE LOGO, GILEAD, and the GILEAD LOGO are trademarks of Gilead Sciences, Inc., or its related companies. 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. For more information on Kite, please visit the company's website at?www.kitepharma.com.?Follow Kite on social media on Twitter (@KitePharma) and?LinkedIn. ______________________________
i? |
TECARTUS??product monograph, June 8, 2021 (www.gilead.ca). |
ii? |
TECARTUS??product monograph, June 8, 2021 ?(www.gilead.ca). |
iii? |
Lymphoma Research Foundation. "Understanding Mantle Cell Lymphoma." Available at: |
iv? |
Wang, M. et al. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N |
v? |
Lymphoma Canada. NHL Subtypes. Available at:?https://www.lymphoma.ca/lymphoma/non-hodgkin- |
vi? |
Canadian Cancer Society. Non-Hodgkin Lymphoma Statistics. Available at: |
vii? |
Lymphoma Canada. NHL Subtypes. Available at:?https://www.lymphoma.ca/lymphoma/non-hodgkin- |
viii |
Wang, M. et al. KTE-X19 CAR T-Cell Therapy in Relapsed or Refractory Mantle-Cell Lymphoma. N |
ix |
TECARTUS??product monograph, June 8, 2021 (www.gilead.ca). |
x |
TECARTUS??product monograph, June 8, 2021 (www.gilead.ca). |
xi |
TECARTUS??product monograph, June 8, 2021 (www.gilead.ca). |
xii |
TECARTUS??product monograph, June 8, 2021?(www.gilead.ca). |
xiii? |
TECARTUS??product monograph, June 8, 2021?(www.gilead.ca). |
xiv |
TECARTUS??product monograph, June 8, 2021?(www.gilead.ca). |
xv |
TECARTUS??product monograph, June 8, 2021?(www.gilead.ca). |