FDA Lets Cancer Trial Resume after 3 Patient Deaths
By Damian Garde,
STAT
| 07. 12. 2016
Federal regulators on Tuesday gave Juno Therapeutics the all-clear to resume testing an experimental cancer treatment, just days after shutting down the trial because of 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.
Continue reading on STAT
Image via Pixabay
Related Articles
Image courtesy National Human Genome Research Institute
The U.S. Food and Drug Administration (FDA) is supposed to encourage effective medical advances while also ensuring that patients and research subjects are protected. This dual mandate demands tricky judgment calls that are made more difficult by outside pressures of several kinds, political, judicial, and especially commercial. This April story at Bloomberg examines one deeply troubling pattern of regulatory capture:
Americans Are Paying Billions to Take Drugs That Don’t Work
Companies are increasingly...
By Elizabeth Chuck, NBC News | 07.09.2024
A Netflix docuseries has put a spotlight on the unregulated world of sperm donation, particularly the lack of stopgap measures that might prevent donors who have been banned by one country from simply going elsewhere to donate more.
Released earlier...
By Amanda Becker and Shefali Luthra, The 19th | 07.08.2024
Image by Duke University Archives from Flickr
Republicans have adopted a slate of policy positions ahead of next week’s convention that does not call for a federal legislative abortion ban, but opens the door to establishing fetal personhood.
The Republican...
By Isabelle Bartram
| 07.17.2024
Image by Kuzzat Altay from Unsplash
Uyghurs, a predominantly Muslim minority in China, are mainly located in the autonomous region of Xinjiang. The Chinese government has pursued an aggressive settlement policy in this region since 1949, with the percentage of Han Chinese in the region increasing from five to forty percent in the second half of the 20th century. Since 2014, the Uyghurs have been subject to persecution and re-education – various sources have estimated that at least one million...
