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Gilead Sciences Receives Approval In Canada For Yescarta

Gilead Sciences Canada, Inc. said that Health Canada has granted a Notice of Compliance or NOC for Yescarta (axicabtagene ciloleucel), a new chimeric antigen receptor T (CAR T) cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL.

YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

YESCARTA is a CAR T cell therapy, also known as a form of immunotherapy, that is custom-made for each patient from his or her own T cells - a type of white blood cell that is part of the immune system and that recognizes and kills foreign cells.

The process works by removing the patient's T cells and genetically altering them with chimeric antigen receptors (CARs). Once reinfused into the patient, the CAR T cells are able to find and attack cancer cells that normal T cells cannot detect.

This cell therapy induces complete response (no detectable cancer) in a proportion of patients with relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma, which are aggressive forms of non-Hodgkin lymphoma (NHL).

YESCARTA will be manufactured by Kite, a Gilead Company (Kite) at its commercial manufacturing facility in El Segundo, California. In the ZUMA-1 pivotal trial, Kite demonstrated a 99 per cent manufacturing success rate with a median manufacturing turnaround time of 171 days.

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