New York, N.Y (USA) and Paris (France), May 21, 2019 – Zionexa, a radiopharmaceutical company specialized in the development and commercialization of innovative molecular imaging companion diagnostics (CDx) for targeted therapies in oncology, today announced that the U.S. Food and Drug Administration (FDA) has accepted its recently submitted New Drug Application (NDA) for FES for filing. FES is a new Positron Emission Tomography (PET) diagnostic drug for the characterization of estrogen receptor status in metastatic breast cancer.
“We are pleased the FDA has accepted our NDA filing and we are looking forward to working in collaboration with the administration during the review process. Filing the NDA for FES represents a key milestone for our young and promising company. Metastatic breast cancer (MBC) is a real health issue with more than 40,000 MBC-related deaths expected in the U.S. in 2019. With prompt and proper treatment, many metastatic breast cancers can be controlled, and mortality deferred. With FES, we would like to offer clinicians a non-invasive and qualitative way to find the optimal treatment for the patient with MBC,” said Peter Webner, CEO Zionexa U.S. Corp.