Shots:

• The approval is based on the (ZUMA-1) & P-II study of axicabtagene ciloleucel. In a P-II study, the same dose of axicabtagene ciloleucel (2.0 x 106 cells/kg) was given as in (ZUMA-1) study in 16 patients with r/r large B-cell lymphoma including DLBCL, PMBCL, t-FL & high-grade B-cell lymphoma
• The results showed an ORR (86.7%), overall safety & tolerability profile was consistent with ZUMA-1 & no DLT was observed
• Yescarta is approved in the US & EU for multiple types of r/r B-cell lymphoma that is developed, manufactured & commercialized by Kite. Upon collaboration in Jan 2017, both companies will also sign an exclusive license agreement to commercialize axicabtagene ciloleucel in Japan

Ref: Gilead | Image: Daiichi Sankyo