FDA places hold on clinical trial of cancer treatment previously reported on KurzweilAI — UPDATE: FDA releases hold
July 13, 2016
Juno Therapeutics, Inc. announced July 7 that it has received notice from the FDA that it has placed a clinical hold on an immune-cell cancer treatment known as the “ROCKET” trial, which was reported on KurzweilAI on Mar. 10, 2016.
The clinical hold was initiated after two patient deaths, which followed the recent addition of fludarabine to the pre-conditioning regimen. Juno has proposed to the FDA to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone.
Further information on Forbes.
UPDATE JULY 13, 2016: Juno Therapeutics announced Tuesday July 12 that the FDA has removed the hold and “the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.” In related news, the Law Offices of Howard G. Smith announced an investigation on behalf of investors of Juno Therapeutics, Inc. (NASDAQ: JUNO) concerning the Company and its officers’ possible violations of federal securities laws and noted that “Juno’s share price fell significantly in value, dropping almost 32%.”