FDA Orphan Drug Designation for ABD-147 for the Treatment of Neuroendocrine Carcinoma

“Neuroendocrine carcinomas, including SCLC and LCNEC, are aggressive and challenging to treat effectively with current systemic therapies,” said Philippe Bishop, M.D., chief medical officer. “By delivering a potent radioisotope to neuroendocrine tumors expressing DLL3 with custom-engineered PK properties, we believe ABD-147 has the potential to become a best-in-class DLL3-targeting treatment for aggressive neuroendocrine tumors. Along with FDA recently granting Fast Track designation to ABD-147 for the treatment of patients with extensive stage small cell lung cancer (ES-SCLC) who have progressed on or after platinum-based chemotherapy, this Orphan Drug Designation for neuroendocrine carcinoma further underscores the potential of ABD 147 development to offer a significant advantage beyond approved drugs.”
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