Phase 3 KT‑US‑740‑0603 Study Evaluating KITE‑753 Versus Axi‑cel in Relapsed/Refractory LBCL

The KITE‑752 Phase 3 randomized controlled study, PALISADES‑2, evaluating the efficacy of KITE‑753 versus axicabtagene ciloleucel (axi‑cel) in adult participants with relapsed or refractory large B‑cell lymphoma (r/r LBCL) following first‑line immunochemotherapy, has been selected for the FAST‑EU Pilot initiative.

This program enables an accelerated coordinated assessment of the initial Clinical Trial Application (CTA) across participating EU Member States (Spain, France, the Netherlands, Italy, Germany, Belgium, Poland and the Czech Republic).

Under FAST‑EU, the combined regulatory authority and ethics committee assessment is expected to be completed within 70 days, compared with timelines exceeding 106 days under standard procedures.

The planned submission date for PALISADES‑2 under FAST‑EU is 06 May 2026. Requests for Information (RFIs) are anticipated around 17 June 2026, with a response window of 12 days, and approval is expected around mid‑July 2026, with exact timelines to be published in CTIS following submission.

France has been designated as the Reporting Member State (RMS) for the FAST‑EU procedure.