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Lutathera Approval Positions Novartis To Regain NET Share Taken By Ipsen

 
• By Eleanor Malone

The US FDA has approved Advanced Accelerator Applications' radiopharmaceutical Lutathera to treat GEP-NETs second time around, just four days after Novartis closed its acquisition of AAA. The product should help the Swiss firm regain ground its Sandostatin product has lost to Ipsen's Somatuline.

Product life cycle
Lutathera approval may help Novartis manage Sandostatin's market decline • Source: Shutterstock

Lutathera (lutetium Lu 177 dotatate) has won US FDA approval to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The peptide receptor radionuclide therapy became the first product to be approved in the US this year, and the first radiopharmaceutical approved by the FDA to treat GEP-NETs, just four days after Novartis AG completed its purchase of the drug's developer, radiopharmaceutical specialist Advanced Accelerator Applications SA.

An Advanced Accelerator Applications spokeswoman said that the list price for Lutathera, which is classified as an orphan drug in...

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Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.