Lantheus first to secure US FDA review for generic Lutathera

12 January 2024

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A generics drugmaker has had its Abbreviated New Drug Application for the radiopharmaceutical 177Lu-PNT2003 accepted by the US Food and Drug Administration.

Massachusetts, USA-based Lantheus Holdings (Nasdaq: LNTH) wants to market the generic version of Lutathera for certain gastroentero-pancreatic neuroendocrine tumors.

The company paid POINT Biopharma (Nasdaq: PNT) over $2 billion for rights to the agent at the end of 2022, together with another candidate, 177Lu-PNT2002.

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