Imugene Limited, an immuno-oncology company, has announced significant progress in its Phase 1b clinical trial for azer-cel (azercabtagene zapreleucel), targeting relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The U.S. FDA has granted Fast Track Designation for azer-cel, aimed at expediting the development and review process for treatments addressing serious conditions with unmet medical needs. This designation provides Imugene with benefits such as more frequent FDA meetings, rolling review of submissions, and potential eligibility for Accelerated Approval and Priority Review. Imugene plans to meet with the FDA in Q4 2025 to discuss a pivotal study for azer-cel, following promising trial results indicating significant patient responses.
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