FDA stopped the clinical trial organized by Juno Therapeutics after three patients died during the testing phase II of the study. The market value for Juno dropped 25% after the news, and FDA immediately started an investigation.
The medicine was known under the name of ROCKET, and it was used in patients with lymphoblastic leukemia.
The Food and Drug Administration took the decision to halt the testing after two patients died of a condition which seemed to be related to the treatment. Another previous death occurred at an early stage of the clinical trial. FDA decided there wasn’t enough evidence that the situation was connected with the new medicine.
All patients had ages under 25. Their deaths were caused by cerebral edema, a condition which might have been provoked by fludarabine.
The company representatives said that it was only the fludarabine regimen at fault for the disastrous outcome of the experiment. The research involved two preconditions, one with cyclophosphamide and the second with fludarabine. Now, the organization wants to ask FDA to continue with the first regimen.
The CEO admitted that the cause of death was related to fludarabine, which created severe neurotoxicity in the organism. He also stated that after the decease of the first patient, the company started an internal review and asked for FDA evaluation commission.
FDA will release a full report on the clinical trial in the next 30 days after Juno will submit all the documentations concerning the clinical trial.
Another concern connected with the tragic incident is the safety of an entire class of treatments that rely on chimeric antigen receptor T cell.
FDA is expected to investigate the issue, as this type of therapy was until now considered to be safe and it was extendedly used in other clinical trials. In order to verify the implications of such treatment, FDA should gather data from different studies and compare the levels of toxicity.
Juno explained that the deaths were caused by a rapid expansion of toxic cells in the bodies of the three patients, a condition that wasn’t observed in other clinical trials and with other regimens.
The experimental treatment involved genetically engineered T cells that were thought to recognize cancer cells and combat them. The genetic condition was combined with standard chemotherapy which includes fludarabine and cyclophosphamide.
Juno will continue its clinical trials for the other treatments involving T cells, while the JCAR017 (the official name of ROCKET) will be stopped until further advice from the FDA.
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