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First Targeted Alpha Therapy Wins FDA Breakthrough Device Designation RadioMedix and Orano Med’s Radioligand Therapy AlphaMedix (lead-212-Dotamtate) is currently in a Phase II trial
2024/03/11

By coupling the alpha particle emitting radioisotopes to tumour-selective carrier molecules, cancer cells can be targeted while leaving healthy cells alone. The US Food and Drug Administration (FDA) has recently granted breakthrough device designation to RadioMedix and Orano Med’s AlphaMedix (lead-212-Dotamtate), a targeted alpha therapy currently in Phase II trials for a rare type of neuroendocrine tumour. The two US-based companies, which are partnered in AlphaMedix’s development, that this is the first FDA breakthrough designation for a targeted alpha therapy, 12 February.

 

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First Targeted Alpha Therapy Wins FDA  Breakthrough Device Designation RadioMedix and Orano Med’s Radioligand Therapy AlphaMedix (lead-212-Dotamtate) is currently in a Phase II trial

Source: Biospace