Oncologic Drugs Advisory Committee

On Wednesday, July 12, 2017, the Oncologic Drugs Advisory Committee (ODAC) supported, by a vote of 10-Yes to 0-No, with no abstentions, the safety and efficacy of tisagenlecleucel by Novartis Pharmaceuticals Corp. (Novartis) for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL).

The PDUFA date, which is the FDA’s goal date to make an approval decision, is October 3, 2017.