Juno’s lead CAR-T slammed with a clinical hold in the last lap ahead of FDA filing
One of Juno’s critical studies for its lead CAR-T therapy has just been indefinitely sidelined following the unexplained death of two patients from neurotoxicity, derailing the company’s plans to seek marketing approval in time for a 2017 launch.
In a nasty surprise for shareholders, Juno announced Thursday afternoon that the FDA had placed a clinical hold on its ROCKET study, a Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia. That hobbles the company just as it entered the last lap in a tight race with Kite Pharma.
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