FDA removes clinical hold on Juno's cancer drug study

The Food and Drug Administration has removed a clinical hold it placed on Juno's mid-stage cancer drug trial after three patients died, according to Reuters.

The FDA halted the study for JCAR015 last week following the death of three patients who died after a chemotherapy agent called fludarabine was added to the trial.

The FDA is allowing Juno to continue the trial under a new protocol that does not include fludarabine.

JCAR015 is an experimental 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.

Shares of the Seattle-based drug company jumped 28 percent after the FDA lifted the clinical hold.

More articles on infection control and clinical quality:

Alzheimer's vaccine could be available soon
Northwell Health wins patient safety awards from the NY hospital association
Patients with more say in treatment have fewer side effects

 

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

 


IC Database-3

Top 40 Articles from the Past 6 Months