Juno able to resume leukemia drug trial, says FDA

13 July 2016

The US Food and Drug Administration has removed the clinical hold on the Phase II clinical trial of JCAR015 in patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), the drug's developer Juno Therapeutics (Nasdaq: JUNO) has announced.

This update on Tuesday led shares in the USA-based biopharma company, which had dropped from a previous $40.82 by around 30% to $27.81 on last week’s news that the trial was being halted, to rise again by 26% to $35.05 in after-hours trading on Tuesday, though they had dipped again slightly to $32.44 in Wednesday morning's trading.

The deaths of two patients led the trial to be stopped, but these were attributed to the addition of fludarabine to the pre-conditioning regimen. The Seattle-based company, which focuses on re-engaging the body’s immune system to improve the treatment of cancer, therefore proposed to the FDA that it would continue with the trial using JCAR015 with cyclophosphamide pre-conditioning alone.

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