投稿一覧に戻る
カイト・ファーマ【KITE】の掲示板
-
>>2
Earlier this month, FDA's Oncologic Drugs Advisory Committee (ODAC) voted 10-0 in favor of approval of another CAR T cell therapy targeting CD19 -- tisagenlecleucel-T (CTL019) from Novartis AG (NYSE:NVS; SIX:NOVN). CTL019 is under Priority Review by FDA to treat pediatric and young adult relapsed or refractory B cell acute lymphoblastic leukemia (ALL). Its PDUFA date is Oct. 3
kaz*ヒト投与可能で一斉摘発ｗ
Kite submits MAA for CAR T therapy
Kite Pharma Inc. (NASDAQ:KITE) submitted an MAA to EMA for chimeric antigen receptor (CAR) T cell therapy axicabtagene ciloleucel (KTE-C19) to treat relapsed or refractory diffuse large B cell lymphoma (DLBCL), transformed follicular lymphoma and primary mediastinal B cell lymphoma in patients ineligible for autologous stem cell transplantation (ASCT). The company said the application is the first CAR T cell therapy submitted in Europe.
Axicabtagene ciloleucel comprises autologous T cells genetically modified to express a chimeric antigen receptor (CAR) targeting CD19. The therapy has PRIority MEdicines (PRIME) designation from EMA for DLBCL.
The product is under FDA Priority Review to treat refractory aggressive non-Hodgkin’s lymphoma (NHL) with a Nov. 29 PDUFA date (see BioCentury Extra, May 26).