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March Bio's Cancer Therapy Gets FDA RMAT Designation

March Biosciences receives FDA RMAT designation for MB-105 CAR-T therapy targeting T-cell lymphoma. Accelerated development pathway for novel cancer treatment addressing unmet medical need.

This development matters because T-cell lymphoma represents one of the most challenging forms of blood cancer to treat, with current therapies offering limited effectiveness and patients facing extremely poor survival outcomes. The RMAT designation accelerates the development timeline for MB-105, potentially bringing a new treatment option to patients years sooner than traditional regulatory pathways would allow. For patients with relapsed or refractory T-cell lymphoma who have exhausted conventional treatments, this represents a crucial new hope. The therapy's targeted approach to CD5-positive cancers could also establish a new treatment paradigm for other hematologic malignancies, potentially transforming care for multiple cancer types where current immunotherapies have shown limited success.