FDA clears Juno Therapeutics’ experimental cancer treatment for further testing

Federal regulators yesterday gave Juno Therapeutics Inc, the nod to resume experimental cancer treatment, only days after shutting down the trial due to the death of three patients.

Shares of Juno vaulted  to $34.85 in after-hours trading following the news. The stock had been trading at over $40 when the drug trial was halted.

Juno is working in a new field of oncology in which scientists remove a patient's white blood cells and rewire them to target cancerous growths.

The study was put on hold by the Food and Drug Administration, last week after three young leukemia patients who had received Juno's experimental immunotherapy developed fatal brain swelling (See: Juno halts clinical trial of cancer therapy after death of three patients ). http://www.domain-b.com/industry/pharma/20160708_cancer_therapy.html

The deaths were blamed by Juno on an unforeseen interaction between those reengineered blood cells, called CAR-Ts, and a chemotherapy drug used to prepare patients for treatment. It proposed resumption of the trial without using the chemotherapy drug.

Following speedy completion of the review, the FDA apparently accepted Juno's explanation for the deaths and cleared the method for further testing with a new drug protocol.

The deaths raised widespread questions about the future of CAR-T therapies, that had led to lasting remissions for some seriously ill patients but had been tested only in small trials. The technology itself was only a few years old, and its long-term safety had not yet been established.

Early studies with the therapy had had encouraging results in the treatment of certain types of leukemia and lymphoma, generating excitement among oncologists, patients and investors.

However, the therapy could provoke severe side effects, especially immune system overreactions and neurological toxicity, including swelling in the brain, known as cerebral edema. Several deaths had been reported due to these side effects.

Juno shares rose 27 per cent in trading after the market closed yesterday, which was about the same as the drop on the day the FDA stopped the trial.