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Expanded Access Data Supported Lutathera Approval, US FDA Notes

 
• By Michael Cipriano

Amid broader debate on right-to-try legislation, review experience of Novartis' oncologic highlights US FDA's argument that expanded access can at least in part contribute to approval of a drug.

As "right-to-try" legislation continues to be debated on Capitol Hill, the US FDA is touting Advanced Accelerator Applications SA's use of an expanded access program in its development of Lutathera (lutetium Lu 177 dotatate), which which was approved Jan. 26.

"[The approval] also demonstrates how the FDA may consider data from therapies that are used in an expanded access program to support approval for a new treatment," Oncology Center of...

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