Reactions 1642, p3 - 11 Mar 2017

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JCAR 015: development ended after deaths Juno Therapeutics, in collaboration with partner Celgene, has ended development of JCAR 015, according to a recent Reuters report, following cases of fatal cerebral oedema. JCAR 015 was one of the company’s lead cell-based cancer immunotherapies based on its chimeric antigen receptor (CAR) technology, which was in clinical trials for treatment of adults with acute lymphoblastic leukaemia (ALL). The phase II development programme was halted twice last year by the US FDA* and remained on hold due to severe neurotoxicity which led to death from cerebral oedema in five patients. Internal investigation by Juno Therapeutics revealed that the risk of severe toxic reactions was increased by multiple factors, including "factors related to the product". The company intends to "redirect resources to development of another product for relapsed or refractory ALL". * see Reactions 1630 p2; 803210791 Reuters. Juno ends development of high-profile leukemia drug after deaths. Internet Document : 1 Mar 2017. Available from: URL: http://www.reuters.com/ 803231024 article/us-juno-leukemia-idUSKBN1685QQ

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Reactions 11 Mar 2017 No. 1642