FDA Orphan Drug Designation for CTD402 for the Treatment of T-Cell Leukemia and Lymphoma
“Receiving orphan drug designation for CTD402 is an important milestone for patients with relapsed or refractory T‑ALL/LBL, who urgently need more effective and accessible treatment options,” said Imviva Biotech Chief Medical Officer Jan Davidson-Moncada, M.D., Ph.D. “This recognition provides regulatory support and extended market exclusivity to advance our development pathway, supporting our belief that a truly off‑the‑shelf CAR‑T therapy, available at the point of care, has the potential to change the treatment paradigm for these rapidly progressing diseases.”
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