PETNET Solutions Inc. and Zionexa USA announced today the FDA approval of the first-ever breast cancer-specific PET imaging agent. Cerianna Fluoroestradiol F-18 can be used as an adjunct to biopsy to detect estrogen receptor-positive lesions in patients with recurrent and metastatic breast cancer.

“These new PET agents don’t come around every day,” Barry Scott, head of PETNET Solutions, told HCB News. “Cerianna is actually the first F-18 oncology PET agent that’s been FDA approved since 2016.”

The introduction of estrogen receptor therapies has significantly improved the outlook for breast cancer patients since most breast cancer is receptor-positive. However, there is a major dilemma when certain patients stop responding to estrogen receptor suppression therapy.

“Despite the utility of these estrogen suppression therapies, tumors mutate over time,” said Peter Webner, CEO of Zionexa. “Metastatic tumors often have very different genetic expression versus the original tumor.”

Currently, the only way to assess receptor expression in breast tumors is through biopsy, but you can only obtain a limited amount of tissue and the tissue can only be retrieved from a small number of tumors. Absent any evidence of ER-negative disease from a biopsy, the current standard of care is to have the patient go from one type of estrogen receptor suppression drug to another until the clinician concludes that their patient has estrogen receptor-negative disease that hasn’t been identified.

“The goal of Cerianna is to assess the estrogen receptor status of pretty much all of the disease of the patient and give the doctor information on the heterogeneity of the estrogen receptor expression,” said Webner.

Metastatic breast cancer patients have a 30% five-year survival rate on average, according to Webner. Although long-term, longitudinal studies have not been conducted yet, he is hopeful that Cerianna can improve that rate.

“A basic measure to ensure success in any sort of treatment is early identification and early and appropriate therapy for the disease,” he explained. “The concept here is providing additional, actionable data for the clinician to be able to make a decision on the best course of therapy for that patient.”

Cerianna will be made commercially available exclusively through PETNET, a Siemens Healthineers company, starting in January. The launch will involve a phased approach that will start with sites in New York, Pennsylvania, California, Florida and North Carolina, followed closely by Illinois, Texas, Washington state.

Since PETNET has 43 cyclotron-equipped radiopharmacies in the country, there will be a lot of room to expand over time, said Scott.

“We will then expand past that in coordination with Zionexa depending on what the market demands,” Scott added.

In states such as New York and Pennsylvania, Cerianna can reach many surrounding states, since its half-life allows it to be easily delivered by ground out to about four hours if needed. PETNET can also fly doses around the country.

In addition to the U.S., Cerianna is also approved for use in France. Just a few months ago it was given authorization for marketing.

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