TON July 2016 Vol 9 No 4 - FDA News & Updates

Diagnostic Imaging Agent FDA Approved for Rare Neuroendocrine Tumors

According to a recent announcement by the US Food and Drug Administration (FDA), Netspot, a radioactive diagnostic agent for positron emission tomography (PET) imaging, has been approved in adult and pediatric patients with somatostatin receptor–positive neuroendocrine tumors.

The agent—gallium Ga-68 dotatate—is a positron-emitting analogue of so­matostatin, a hormone that regulates the endocrine system. Neuroendocrine tumors have receptors for this hormone, and gallium Ga-68 dotatate works by binding to them.

This FDA approval was based on 3 studies evaluating the safety and efficacy of Netspot, all of which confirmed the usefulness of Ga-68 dotatate images in locating neuroendocrine tumors.

Netspot is supplied as a sterile, single-dose kit, for preparation of a Ga-68 dotatate intravenous injection; serious adverse reactions have not been identified with use of this agent.


US Food and Drug Administration. FDA approves new diagnostic imaging agent to detect rare neuroendocrine tumors. Published June 1, 2016. Accessed June 22, 2016.

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Diagnostic Blood Test FDA Approved for NSCLC Gene Mutation

The Cobas EGFR (epidermal growth factor receptor) Mutation Test v2 is the first blood-based genetic test approved by the FDA for detecting EGFR gene mutation in patients with non–small-cell lung cancer (NSCLC). This test is a companion diagnostic for erlotinib (Tarceva; Astellas Pharma US, Inc, and Genentech, Inc).

"Approvals of liquid biopsy tests make it possible to deliver highly individualized health care for patients," explained Alberto Gutierrez, PhD, Director, Office of In Vitro Diagnostics and Radiological Health, FDA Center for Devices and Radiological Health, Silver Spring, MD, in a press release by the organization.

The test can detect the presence of specific NSCLC mutations in patients' blood samples, and help select those who may benefit from treatment with erlotinib. A tumor biopsy should be performed to determine whether mutations are present if they are not detected in the blood, the FDA noted.

The efficacy of the Cobas EGFR Mutation Test v2 was evaluated among patients in a clinical trial whose tumor biopsies were previously confirmed as positive for the EGFR exon 19 deletion or L858R mutations.


US Food and Drug Administration. FDA approves first blood test to detect gene mutation associated with non-small cell lung cancer. Published June 1, 2016. Accessed June 22, 2016.

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Axumin FDA Approved for Recurrent Prostate Cancer

With prostate cancer the second leading cause of cancer-related death among US men, accurate staging is paramount in improving management and outcome among patients with suspected cancer recurrence after their primary treatment.

In a recent announcement, the FDA has stated its approval of axumin, an injectable radioactive agent. Axumin is indicated for PET imaging in men with suspected cancer recurrence, based on elevated prostate-specific antigen levels following prior treatment.

This approval was based on data from 2 studies that evaluated the safety and efficacy of axumin for imaging prostate cancer in patients with recurrent disease. The most commonly reported side effects among patients receiving axumin were pain and redness at the injection site, and a metallic taste in the mouth.


US Food and Drug Administration. FDA approves new diagnostic imaging agent to detect recurrent prostate cancer. Published May 27, 2016. Accessed June 22, 2016.

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Last modified: July 27, 2016