FDA lifts hold on Juno's JCAR015

Juno Therapeutics Inc. (NASDAQ:JUNO) gained $6.96 (25%) to $34.75 in early after-hours trading Tuesday after it said FDA lifted a clinical hold on the company's Phase II ROCKET trial of JCAR015 to treat relapsed or refractory acute lymphoblastic leukemia (ALL). FDA placed the hold last Thursday after the company reported two patient deaths from cerebral edema in the trial (see BioCentury Extra, July 7).

Juno said it revised ROCKET's protocol by eliminating fludarabine treatment from the pre-conditioning regimen. Last week, President and CEO Hans Bishop said the deaths were likely associated with the addition of fludarabine to a cyclophosphamide lymphodepletion regimen. The two deceased patients, as well as a third ROCKET patient whose death was not ruled as treatment-related, had received fludarabine. ...