Morning Briefing
Summaries of health policy coverage from major news organizations
After 3 Patient Deaths, Juno Therapeutics To Resume Modified Trial Of Anti-Cancer Treatment
The Wall Street Journal: Juno To Resume Clinical Trial Of Anticancer Treatment
Juno Therapeutics Inc. will resume a drug trial of a potential leukemia treatment that had been placed on clinical hold last week following two patient deaths. The U.S. Food and Drug Administration has removed the hold, Juno said Tuesday. The two deaths, and another in May, occurred in a Phase 2 study of Juno’s experimental treatment JCAR015 in adult patients with B cell acute lymphoblastic leukemia. (Beckerman, 7/12)
Stat: FDA Lets Cancer Trial Resume After Three Patient Deaths
Juno is at work in a newfangled field of oncology in which scientists remove a patient’s own white blood cells and rewire them to home in on cancerous growths, part of the growing field of immunotherapy. The Food and Drug Administration put the study on hold last week after three young leukemia patients who had received Juno’s experimental therapy developed fatal brain swelling. Juno blamed the deaths on an unforeseen interaction between those reengineered blood cells, called CAR-Ts, and a chemotherapy drug used to prepare patients for treatment. It proposed resuming the trial without using that chemotherapy drug. (Garde, 7/12)
The Associated Press: Study Of Juno Therapeutics Leukemia Treatment Is Allowed To Resume
A study of an experimental treatment for leukemia that was halted last week after the death of two patients has been allowed to resume after a modification. The Food and Drug Administration suspended a trial by Juno Therapeutics after the company reported that two patients had died from swelling of the brain. Juno said the problem stemmed not from its treatment but from a chemotherapy drug used in pretreatment. The agency said it would allow the trial to resume without the chemotherapy drug. (7/12)
Boston Globe: Now What? How Biotechs Deal With Failure
In biotechnology, failure is more the rule than the exception. Nine out of 10 companies that begin clinical trials never bring a drug to market. And for those that make it out of the gate, clinical, regulatory, or competitive setbacks are common. Last week, Juno Therapeutics Inc., a highflier in the field of engineering the immune system’s T cells to kill cancer tumors, halted a study of its leading drug candidate after three patients died. The Seattle company’s stock fell more than 30 percent. How companies respond to setbacks — whether they are blindsided or clear-eyed, devastated or determined to recover — is telling, said Laurie Halloran, president of Halloran Consulting Group, a Boston firm that advises life sciences companies. (Weisman, 7/12)
