FDA Grants Priority Review for Kite’s Lymphoma Treatment
Kite Pharma received a priority review designation from the FDA for its investigational CAR T-cell therapy KTE-X19 for treating adults with relapsed or refractory mantle cell lymphoma (MCL).
The drugmaker submitted the BLA based on the results of a phase 2 clinical trial, which showed that 93 percent of patients responded to a single infusion of the drug, with 67 percent of patients achieving a complete response.
The therapy has been granted breakthrough therapy designation by the FDA and Priority Medicines (PRIME) designation by the EMA for relapsed or refractory MCL. The EMA recently approved the KTE-X19’s marketing application.