Shots:

• The MAA is based on P-II ZUMA-2 study assessing KTE-X19 in 74 patients aged ≥18yrs. with MCL whose diseases is refractory & relapsed following up to five prior therapies including anthracycline/ bendamustine-containing CT- anti-CD20 mAb and the BTK inhibitors (ibrutinib/ acalabrutinib)
• The P-II ZUMA-2 study results: ORR (93%); CR (67%) as assessed by IRRC following a single infusion of KTE-X19 (median follow-up of 12.3mos.). Following the approval- KTE-X19 would be the first CART cell therapy for MCL
• KTE-X19 is an investigational- autologous- anti-CD19 CART cell therapy- being evaluated in P-I/II study in ALL- MCL and CLL and has received FDA’s BT and EMA’s PRIME designation. On Dec 11- 2019- Kite has submitted BLA to the US FDA for the therapy

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Biobuzz