- Novartis AG company Advanced Accelerator Applications SA on Friday won FDA approval for its nuclear medicine Lutathera to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
- Lutathera links a targeting molecule and a radioactive component and is the first FDA-approved peptide receptor radionuclide therapy (PRRT). The OK also marks the first time a radiopharmaceutical has been approved for the treatment of GEP-NETs.
- Approval was supported by two studies, including Phase 3 results from the NETTER-1 study which showed Lutathera met its primary endpoint. Treatment with Lutathera plus standard-of-care led to a 79% reduction in the risk of disease progression or death compared to standard treatment alone.
Novartis acquired Advanced Accelerator for $3.9 billion last October, closing the deal last week — just in time for the FDA's target decision date for the nuclear medicine company's lead radioligand therapy, Lutathera (lutetium Lu 177 dotatate).
In the NETTER-1 study, median progression-free survival had not been reached in the Lutathera arm, versus 8.5 months for the 60 mg octreotide LAR arm. Objective response rate, composed of complete and partial responses, was 13% for the Lutathera arm compared to 4% in the Octreotide LAR arm.
"For 30 years, Novartis has supported the NET community with the development of therapeutics in NET and carcinoid syndrome," said Susanne Schaffert, chair and president, Advanced Accelerator Applications, in a statement.
Roughly one in 27,000 people are diagnosed with GEP-NETs each year, and patients with neuroendocrine tumors with distant metastases have a five-year survival probability of around 35%.
There are a few other companies developing therapeutics for NETs. They include Tarveda Therapeutics Inc.'s PEN-221, which targets the somatostatin receptor and carries a potent cytotoxic, and is expected to move into Phase 2a in first quarter of 2018; and OctreoPharm Sciences GmbH's 177Lu-OPS201 PRRT, which has been assessed under compassionate use in a pilot study.
"GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing," commented Richard Pazdur, director of the FDA's Oncology Center of Excellence, in a Jan. 26 statement. "This approval provides another treatment choice for patients with these rare cancers."
As well as adding Lutathera and 177Lu-PSMA-R2 (in Phase 1/2 study in prostate cancer) to Novartis' oncology portfolio, the acquisition of Advanced Accelerator Applications also brings on board a portfolio of diagnostics. These include NETSPOT/SOMAKIT and F-18 PET.