July 12, 2016 6:42pm
The trial is known and named "ROCKET” – how appropriate!
JUNO was given the green light to resume a crucial clinical trial Tuesday, less than a week after federal health regulators halted the P2 study on a potential cancer treatment on the heels of patients dying.
The FDA last week requested that Juno submit a complete response to the hold, which would require the company to revise several documents including its informed consent form and trial protocol.
The Bottom Line: Under the revised protocol, the ROCKET trial will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning only.