Tags : KTE-X19

Kite’s KTE-X19 Receives the US FDA’s Priority Review for Relapsed

Shots: The US FDA has accepted BLA and granted PR designation to Kite’s KTE-X19 for the treatment of patients with r/r MCL The BLA is based on P-II ZUMA-2 study assessing KTE-X19 in 74 patients aged ≥18yrs. with r/r MCL following up to prior 5L therapies including an anthracycline, bendamustine-containing CT, anti-CD20 mAb and the […]Read More

Kite Reports the Validation of EMA’s MAA for KTE-X19 to

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 […]Read More