Juno's Ph. 2 Clinical HOLD removed 2 weeks after 2 deaths Jul 12 2016
The biopharmaceutical company Juno Therapeutics was given the green light to resume a crucial clinical trial Tuesday, less than a week after federal health regulators halted the phase 2 study on a potential cancer treatment on the heels of two patients dying.
November 23, 2016
Two more cancer patients just died in a clinical trial. Should the FDA be blamed? When three cancer patients died earlier this year while on an experimental therapy, the Food and Drug Administration promptly halted the clinical trial. A few days later, the hold was lifted — a turnaround so fast that it stunned the world of drug development.
On Wednesday, the company behind the trial said two more patients were dead.
“In light of what happened, I think the FDA really dropped the ball,” said Maxim Jacobs, a health care analyst at Edison Investment Research who researches oncology drugs.
Juno Halts Development of CAR T-Cell Cancer Immunotherapy Candidate JCAR015
March 2, 2017
Juno Therapeutics has halted development of JCAR015, its lead chimeric antigen receptor (CAR) T-cell cancer immunotherapy indicated for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), nearly 4 months after placing a Phase II trial of the candidate on its second clinical hold following two additional patient deaths.