RadioMedix and Orano Med’s AlphaMedix Receives the US FDA’s Breakthrough Therapy Designation for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
Shots:
- The US FDA has granted BTD to RadioMedix and Orano Med’s AlphaMedix (212Pb-DOTAMTATE) to treat adults with unresectable/metastatic, progressive somatostatin receptor-expressing GEP-NETs who are not treated with peptide receptor radionuclide therapy (PRRT)
- The designation was supported by the data from P-I, demonstrating an ORR of 62.5%, & an ongoing P-II studies investigating the safety and efficacy of AlphaMedix. The target response rate has been attained in the P-II while top-line results are anticipated in mid-2024
- AlphaMedix comprises of SSTR-targeting peptide complex radiolabeled with 212Pb which produces alpha particles for destroying cancer cells while reducing toxicity to nearby healthy tissues
Ref: Oranomed | Image: Radiomedix
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
