Zionexa has distributed the first doses of its PET imaging tracer, Cerianna, for breast cancer detection in the U.S.

Zionexa distributes first FDA-approved estrogen-receptor-based PET tracer in U.S.

December 09, 2020
by John R. Fischer, Senior Reporter
Zionexa US Corp., a wholly owned subsidiary of biotech company Zionexa SAS, has distributed the first doses of Cerianna (Fluroroestradiol F-18) for breast cancer imaging.

The molecular imaging tracer is the first FDA-approved F-18 PET imaging biomarker developed specifically to assess patients with recurrent or metastatic breast cancer, according to Peter Webner, CEO of Zionexa US Corp.

“Cerianna can help guide therapies for recurrent and MBC patients and our ambition is to provide [for] all patients who have the need for it in the United States," said Webner in a statement.

Cerianna is designed to to detect estrogen-receptor-positive lesions on PET scans and act not as a replacement but an adjunct to biopsies in patients with recurrent or metastatic breast cancer. The radiopharmaceutical was FDA-approved in May, with doses now delivered to two oncology imaging centers in the San Francisco area through Siemens Healthineers PETNET solutions, the exclusive commercial manufacturer and distributor of Cerianna in the U.S.

While 80% of patients with estrogen-receptor positive disease show long-term durable response to estrogen suppression therapy, 30% still progress. Webner, who recently was the guest of a Five Minutes in Healthcare interview with HealthCare Business News, says that biopsies are used in such cases to determine if the tumor is no longer responding to estrogen suppression therapy or has lost its estrogen receptors. The latter, he says, occurs to some degree for 20% to 40% of cases of estrogen-receptor positive breast cancer.

A radiolabeled version of estrogen, Cerianna attaches to the same binding sites on cells that estrogen suppression chemotherapeutics target. If all tumors light up on a scan using the tracer, it indicates that the cancer is entirely estrogen driven. Tumors that do not light up are ones that will no longer respond to estrogen suppression therapy. “Those are usually the cause of progression,” said Webner in the interview.

The problem with this, he adds, is that usually by the time patients show evidence of progression, the cancer has advanced beyond one or two tumors. “This [Cerianna] gives availability of data to the doctor to potentially make a decision much earlier and drive the patient to a more appropriate therapy much sooner during the course of progression.”

The tracer will be distributed next month in Los Angeles, New York, Philadelphia, Raleigh Durham and Jacksonville.