The panel voted unanimously, 10-0, to recommend that the FDA give its official nod. The company’s therapy genetically alters a patient’s own cells to fight acute lymphoblastic leukemia.
“The panel’s unanimous recommendation in favor of CTL019 moves us closer to potentially delivering the first-ever commercially approved CAR-T cell therapy to patients in need,” CEO of Novartis Oncology, Bruno Strigini, said in prepared remarks. “We’re very proud to be expanding new frontiers in cancer treatment by advancing immunocellular therapy for children and young adults with r/r B-cell ALL and other critically ill patients who have limited options. We look forward to working with the FDA as they complete their review.”
To use Novartis’ therapy, a separate treatment must be made for every patient. The patient’s cells are removed, frozen and shipped to Novartis, where they are thawed and processed and then sent back to the patient’s treatment center.
At the company’s presentation before the FDA panel yesterday, Novartis reportedly said that the turnaround time for the entire process is down to 22 days.
Novartis touted data from a study involving 63 patients who received the treatment in 2015 – 82.5% of those patients went into remission after one year of treatment.
The advisory panel questioned the company over secondary issues relating to the treatment. Specifically, they raised concerns about severe side effects that some patients experienced during the trial, including lung congestion and high fevers.
But nevertheless, the vote went just as Novartis could have hoped – and the FDA is expected to green-light the therapy. It is currently under priority review at the agency.
Novartis said it plans to initially limit the use of its CAR-T treatment to, at most, 35 medical centers in the U.S.