FDA approves Advanced Accelerator Applications' diagnostic agent for rare tumors

The FDA has approved a novel PET imaging diagnostic agent for neuroendocrine tumors from Advanced Accelerator Applications ($AAAP). The nod comes 7 months after the French radiopharmaceutical diagnostics player raised $75 million in its IPO.

Known as Netspot, it is a sterile, single-dose kit for the preparation of gallium Ga 68 dotatate injection, a radioactive agent used in PET imaging to spot tumors in patients with the rare condition somatostatin receptor positive neuroendocrine tumors, or NETs. NETs develop in the hormone-producing cells in the endocrine system, which can be found throughout the body. The tumors can be benign or cancerous, and can go undetected for years, delaying diagnosis. Ga 68 dotatate binds to receptors on a NET in the place of the hormone somatostatin, thereby indicating the tumor's location.

Netspot, also called Somakit-TATE outside the U.S., previously won FDA priority review and orphan drug status from the FDA and the European Medicines Agency.

"Use of advanced imaging techniques to detect rare neuroendocrine tumors at an early stage in patients is critical," said Dr. Libero Marzella,director of the Division of Medical Imaging Products in the FDA's Center for Drug Evaluation and Research, in an FDA statement. "Netspot provides another diagnostic tool whose results will help clinicians determine the location and extent of the tumor. This information is important for planning the appropriate course of therapy."

The company proved safety and efficacy in three clinical trials. One compared Ga 68 dotatate images of NETs with images taken with an approved drug, while another evaluated Netspot images against tissue studies and clinical follow-up. The third trial measured the usefulness of Ga 68 dotatate images in patients who had recurring NETs. No serious adverse reactions were identified.

AAA, which is valued at about $1.2 billion, has a number of products in its pipeline, including diagnostics and therapeutics for various cancers. It markets multiple PET tracers in Europe, for oncology, cardiology, neurology and infectious/inflammatory disease. On May 31, the company reported €26.9 million ($30.65 million) in sales during Q1 this year, a 29.6% boost over the €20.8 million ($23.6 million) reported the same quarter a year earlier. CEO Stefano Buono indicated plans to launch Netspot/Somakit and Lutathera, another somatostatin analogue for the treatment of NETs, but didn't specify a timeline.

- here's the FDA statement
- and here's AAA's statement

Editor's note: This story has been corrected to say Lutathera is a somatostatin analogue used as a therapy for NETs and not a diagnostic as previously stated.