Juno Therapeutics LogoThis is an important and necessary follow-up to the ongoing Juno JCAR015 story in July after three patients had died due to complications associated with cerebral oedema. At that time, the company attributed the deaths to the inclusion of fludarabine in the lymphodepletion given prior to CAR T cell therapy infusion, leading to severe neurotoxicity, and clinical hold was lifted by FDA after the protocol was subsequently amended.

This morning came the dramatic announcement that following the protocol amendment, Juno has voluntarily placed the ROCKET trial on clinical hold again following another two deaths from cerebral oedema.

What gives and what are the consequences here?

We take a joint look at some of the issues that arise from this situation in terms of the CAR T cell therapy market and also pen thoughts from the analyst call this morning.

Subscribers can log-in below or you can learn more about our insights by clicking on the blue box…

Posted by 

Purchase Access to Premium Content

PLEASE READ BEFORE YOU BUY. Click on blue icon to purchase a PERSONAL, INDIVIDUAL license to premium content. Please READ our TERMS OF USE before purchasing (link at bottom of page): You are NOT PERMITTED to share access or copies of posts. If you work for a CONSULTING FIRM, AGENCY, or are in PR or COMMUNICATIONS you cannot purchase an INDIVIDUAL license through this site without prior approval (even if your use is personal) and typically a CORPORATE license will be required. Please CONTACT US to discuss how you might use our content & obtain a quote for the appropriate license. Rates may change without notice and are non-refundable. If you in any doubt about whether you can buy through the blue icon, PLEASE CONTACT US first.