- Oncternal Therapeutics (NASDAQ:ONCT) announces agreement with FDA on phase 3 registrational study design for zilovertamab in the treatment of mantle cell lymphoma (MCL).
- The FDA also provided positive feedback on the proposed clinical and regulatory requirements of the development program for zilovertamab in MCL.
- The primary endpoint of the phase 3 superiority clinical trial ZILO-30, intended to support submission of a biologics license application, will be progression-free survival.
- The study will be conducted internationally in at least 50 centers and is expected to begin in Q2.