20:21 , Jul 21, 2017 |  BioCentury  |  Strategy

Accessing miracles

With unanimous backing of an FDA advisory committee, overwhelming efficacy and a robust REMS, all signs suggest Novartis AG’s tisagenlecleucel-T is headed to the market for children and young adults with a rare leukemia. The...
18:44 , May 26, 2017 |  BC Extra  |  Company News

Priority Review for Kite's CAR T therapy

Kite Pharma Inc. (NASDAQ:KITE) said FDA accepted and granted Priority Review to a BLA for chimeric antigen receptor (CAR) T cell therapy axicabtagene ciloleucel (KTE-C19) to treat refractory aggressive non-Hodgkin’s lymphoma (NHL). The PDUFA date...
07:00 , Jun 20, 2016 |  BC Week In Review  |  Clinical News

Anti-CD19 chimeric antigen receptor: Updated Phase I data

Data from 22 patients with DLBCL, follicular lymphoma or mantle cell lymphoma (MCL) in an open-label, U.S. Phase I trial showed that a single infusion of anti- CD19 CAR T cells given 2 days after...
07:00 , May 30, 2016 |  BC Week In Review  |  Clinical News

Anti-CD19 chimeric antigen receptor: Phase I data

Data from 19 patients with various subtypes of DLBCL in an NIH-funded Phase I trial showed that a single infusion of anti- CD19 CAR T cells given 2 days after completion of low-dose conditioning chemotherapy...