FDA Accepts New Drug Application for the Radiopharmaceutical Imaging Kit EVG-001 for NETs

FDA

The FDA has accepted a new drug application (NDA) for EVG-001, a kit for the preparation of Gallium-68 DOTATOC injection, a radiopharmaceutical approved for imaging of neuroendocrine tumors (NETs) using positron emission tomography (PET), according to an announcement from Evergreen Theragnostics, Inc.¹

The FDA has set a target action date of July 20, 2023, under the Prescription Drug User Fee Act. If approved, doses prepared using EVG-001 are expected to be made available beginning in the third quarter of 2023.

“Gallium-68 DOTATOC imaging has been clinically used in Europe for well over a decade,” James Cook, president and chief executive officer of Evergreen Theragnostics, said in a press release. “The University of Iowa took an important step in 2019 by gaining FDA approval for their own NDA for Gallium-68 DOTATOC, produced locally at the University of Iowa. If approved, this NDA will build on that by making Ga-68-DOTATOC imaging available nationwide for neuroendocrine tumor patients, in the form of an easy-to-use kit for radiopharmacies. We thank the University of Iowa for leading the way in this space, as well as for their support and contribution to this application.”

Ga-68-DOTATOC is injected intravenously prior to a PET scan to identify the tumor.²

On August 21, 2019, the FDA approved Ga-68 DOTATOC for the detection of somatostatin receptor positive NETs based on findings from 3 clinical trials: (NCT1619865 [trial 1]; NCT1869725 [trial 2]; NCT2441062 [trial 3]), which enrolled 334 patients with known or suspected NETs.

In trials 1 and 2, Ga-68-DOTATOC successfully identified NETs approximately 90% to 92% of the time.

“It’s very encouraging to see this move forward. The long-term goal of our work at the University of Iowa has always been to make Ga-68-DOTATOC more widely available to patients in the United States,” said John Sunderland, PhD, MBA, professor of radiology at the University of Iowa. “The efforts of Evergreen Theragnostics will almost certainly extend the availability of Gallium-68 DOTATOC to the NET patient population of the United States for future years to come, extending the primary vision of the researchers here at Iowa.”

“This filing represents the first NDA for Evergreen Theragnostics, and an important step forward as we broaden our portfolio of offerings,” Cook added. “This significant achievement complements our ongoing commitment to our core CDMO[(Contract Development and Manufacturing Organization] business.”

Regarding safety, Ga-68-DOTATOC is a radioactive drug, which may increase the risk of lifetime radiation exposure. The most common adverse effects include nausea, itching, and flushing.

References

1. Evergreen Theragnostics Submits New Drug Application for Gallium-68 DOTATOC Kit with US FDA. News release. Evergreen Theragnostics, Inc. December 13, 2022. Accessed December 13, 2022. https://prn.to/3YnyCyc
2. Drug Trials Snapshots: Ga-68-DOTATOC. FDA. Accessed December 13, 2022. https://bit.ly/3uMysmB