FDA Releases Hold on Juno's ROCKET Trial

The ROCKET trial was halted last week following news of 3 patient deaths due to cerebral edema.

Juno Therapeutics has received a go ahead to resume its trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia, called the ROCKET trial. The trial was halted last week following news of 3 patient deaths due to cerebral edema.

The deaths, according to Juno, occurred after fludarabine was included in the preconditioning regimen, along with cyclophosphamide. Preconditioning helps make the patient more receptive to the CAR-T treatment.

Company officials met with the FDA last week and were hopeful that the data that they submitted would convince the regulators to give them a go-ahead, which they did. “We are recommending to the FDA that we use cyclophosphamide alone to reduce patient exposure. We anticipate that the FDA will review our submission in an expedited fashion, but it could take up to 30 days for them to make a decision,” Mark Gilbert, MD, senior vice president and chief medical officer at Juno, had said during a conference call. The FDA review and acceptance of Juno’s decision to use cyclophosphamide alone has come in quite quickly.

The Boston Globe has reported that the FDA is placing additional scrutiny on other companies that are developing CAR-T cell treatments, including Novartis and Kite Pharma.

Shares of Juno spiked nearly 28% following FDA’s consent.