Lyell Immunopharma announces FDA granted RMAT designation to LYL314

Lyell Immunopharma (LYEL) announced that the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy, RMAT, designation to LYL314 for the treatment of adult patients with relapsed and/or refractory large B-cell lymphoma after two or more prior lines of therapy. LYL314 is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19-targeted CAR T-cell therapies for the treatment of aggressive large B-cell lymphoma. RMAT designation provides all the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interactions with the FDA. LYL314’s RMAT designation was granted based on promising early data from the ongoing Phase 1/2 clinical trial.