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FDA suspends Juno Therapeutics cancer drug trial after patient deaths

pharmafile | July 8, 2016 | News story | Medical Communications, Research and Development FDA, juno therapeutics, patient deaths 

Juno Therapeutics (NASDAQ: JUNO) has had its Phase II trial investigating JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukaemia suspended by the US Food and Drug Administration (FDA) after the death of two trial patients last week.

The deaths followed the recent addition of chemotherapy drug, Fludarabine, to the pre-conditioning program, according to Juno. The company wants to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone.

The FDA, who has placed a clinical hold on the trial, responded to Juno’s suggestion with requests for a revised informed consent form, a revised investigator brochure, a revised trial protocol, and a copy of the presentation made to the agency.

The company also indicates that its other CD19-directed CAR-T cell product candidates are not affected by this incident.

This news has been enough to send shares at the company tumbling almost 30% in after-hours trading, with value of stock expecting to fall sharply when the market opens.

Juno chief executive, Hans Bishop, says: “This is a humbling experience. No doubt it is difficult for the physicians who are looking after these patients and their families. Clearly these therapies are potent, that’s why they offer the potential for cures.”

Sean Murray

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