Zionexa US Corp., a wholly owned subsidiary of Zionexa SAS, specialized in the development and commercialization of in-vivo biomarkers for use in guiding targeted therapies in oncology, announced that the Center for Medicare and Medicaid Services (CMS) has approved transitional pass-through status and reimbursement through a C-code for Cerianna (fluoroestradiol F-18) injection.

 

Cerianna (fluoroestradiol F-18) injection is a new molecular imaging agent approved by the Food and Drug Administration (FDA) indicated for use in positron emission tomography (PET) imaging for the detection of estrogen receptor-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer (MBC). Cerianna (fluoroestradiol F-18) is the first FDA-approved F-18 PET imaging agent specifically indicated for use in patients with recurrent or metastatic breast cancer. The temporary code, C9060, is effective since October 1, 2020. The permanent code will be expected in January 2021.

 

Receiving the pass-through status and the C-code for Cerianna is a very important step in our process to get our new molecule commercialized in the United-States and provide physicians access to a non-invasive and qualitative way to find the optimal treatment for the patient with MBC. MBC is a real health issue with more than 40,000 MBC-related deaths expected in the U.S. in 2019,” said Peter Webner, CEO of Zionexa USA. ”Our team continues to organize and optimize on our commercial and production strategy and we expect a launch at the end of 2020.”

 

About Metastatic Breast Cancer

Metastatic breast cancer is the most advanced stage of breast cancer. Also called stage IV or advanced breast cancer, MBC means that the cancer has spread beyond the breast to other parts of the body. MBC affects more than 168,000[1] patients in the United-States.

[1] Mariotto et al, 2017

 

Download the press release here.

 

INDICATION

CERIANNA is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) imaging for the detection of estrogen receptor (ER)-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer.

Limitations of Use
Tissue biopsy should be used to confirm recurrence of breast cancer and to verify ER status by pathology. CERIANNA is not useful for imaging other receptors, such as human epidermal growth factor receptor 2 (HER2) and the progesterone receptor (PR).

IMPORTANT SAFETY INFORMATION

Adverse Reactions – Reported adverse reactions include: injection site pain and dysgeusia.

Radiation Risks – Ensure safe drug handling and patient preparation procedures to protect patients and health care providers from unintentional radiation exposure.

Risk of Misdiagnosis – Do not use CERIANNA in lieu of biopsy when biopsy is indicated in patients with recurrent or metastatic breast cancer.

Contraindications – None.

Use in Specific Populations – Lactation: Interrupt breastfeeding.

Advise a lactating woman to avoid breastfeeding for 4 hours after CERIANNA administration

To report SUSPECTED ADVERSE REACTIONS, contact Zionexa US Corp at +1.844.946.6392 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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