The deaths of two patients has led the US Food and Drug Administration to put a clinical hold on the Phase II trial of JCAR015, a leukemia drug being developed by USA-based biopharma company Juno Therapeutics (Nasdaq: JUNO).
Juno’s share price dropped by 28.8% to $29.06 in pre-market trading today, as investors reacted to the halting of the ROCKET trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).
The death of two patients last week followed the recent addition of fludarabine to the pre-conditioning regimen, Juno has stressed, and it has proposed to the FDA to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone.
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