YESCARTA

STN: BL 125643
Proper Name: axicabtagene ciloleucel
Trade Name: YESCARTA
Manufacturer: Kite Pharma Inc.
Indication:

For the treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy; 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; adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Product Information

Package Insert and Medication Guide - YESCARTA
Demographic Subgroup Information - axicabtagene ciloleucel (YESCARTA)
Refer to Section 1.1 of the clinical review memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.

Product Information

Supporting Documents