FDA stops Juno's cancer drug trials after 3 patients die

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The Food and Drug Administration halted Juno Therapeutics' clinical trial for an experimental cancer drug following the death of three patients, according to Reuters.

 

JCAR015 is a chimeric antigen receptor T cell therapy that involves extracting a patient's immune system T cells, altering their DNA to improve their ability to detect and kill cancer cells, and then infuse them back into the patient.

 

Two leukemia patients involved in the trial died last week, while a third passed away in May. The deaths of the three patients, all in their 20s, were linked to brain swelling, according to the Seattle-based drugmaker.

 

These types of experimental medicines can cause cytokine release syndrome, which is a buildup of toxic materials from dead cancer cells that can damage healthy tissue and lead to swelling. Usually, the inflammation is controlled with steroids or other treatments.

 

Juno planned to seek approval of JCAR015 by early 2017. Hans Bishop, CEO of Juno, said he expects to have more clarity on the drug's timeline upon further discussions with the FDA in the next few weeks.

 

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