Juno Therapeutics has FDA approval to restart a cancer-treatment trial after it was halted last week over two patients’ deaths.
The FDA halted Juno’s “Rocket” clinical trial after the company reported that two patients undergoing treatment had died. Juno determined the deaths resulted from swelling in the brain caused by a new drug that had been added to the treatment.
The trial seeks to treat patients with relapsed acute lymphoblastic leukemia by using engineered T-cells to attack cancer cells.
Juno added the chemotherapy drug fludarabine to the treatment plan as part of an early step that gets the patient’s body ready for the T-cell injection. Previously, Juno was using only cyclophosphamide in that part of the treatment.
Under an agreement with the FDA, Juno will continue the trial without fludarabine, using only cyclophosphamide instead.
The company’s stock price, which fell more than 30 percent after the clinical hold was announced, was trading up more than 26 percent to $35.25 in after-hours trading Tuesday.