Just days after shutting down tests of a groundbreaking new cancer therapy in the wake of three patient deaths, the US Food and Drug Administration has said the trials can resume. So what changed?
Late last week, it was reported that three leukemia patients had died in a Juno Therapeutics Phase II clinical trial that’s assessing a revolutionary new therapy, called JCAR015, that uses genetically engineered immune cells to treat cancer. In response, the US Food and Drug Administration ordered a temporary halt to the trial—temporary being the key word. Just days later, it’s letting the cancer trial resume.