Blue Earth Diagnostics Receives FDA New Drug Application Acceptance for 18F-rhPSMA-7.3

The company milestone brings it one step closer to advancing its current prostate cancer portfolio.

Katie Hobbins, Managing Editor

September 28, 2022

3 Min Read
Image courtesy of Business Wire

Blue Earth Diagnostics, a company developing and commercializing innovative PET radiopharmaceuticals, recently announced the FDA acceptance of its filing for a New Drug Application (NDA) for 18F-rhPSMA-7.3, an investigational radiohybrid prostate-specific membrane antigen-targeted (PSMA) PET imagining agent. The NDA submission is for the use of 18F-rhPSMA-7.3 in diagnostic imaging of prostate cancer.

Prostate cancer is the second most frequently diagnosed cancer in men and the fifth leading cause of death worldwide. The cancer is most commonly diagnosed in men aged 65 years and over.

“Prostate cancer is a leading cause of male cancer-related death worldwide, and accurate localization and staging of the disease is critical in establishing optimal medical management strategies,” said Eugene Teoh, MBBS, MRCP, FRCR, D.Phil., chief medical officer of Blue Earth Diagnostics. “We believe that the performance of 18F-rhPSMA-7.3, its high PSMA binding affinity and potential for low bladder activity will make it a valuable diagnostic tool that is radiolabeled with 18F for high image quality and readily available patient access.”

18F-rhPSMA-7.3 is an investigational agent that consists of a radiohybrid PSMA-targeted receptor ligand that attaches to and is internalized by prostate cancer cells and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds are referred to as radiohybrid (rh) because each molecule possesses three distinct domans.

“The first consists of a Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells,” according to the press release announcing the NDA acceptane. “It is attached to two labelling moieties which may be radiolabeled with either 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology.”

The company milestone brings it one step closer to advancing its current prostate cancer portfolio, noting that, subject to FDA approval, Blue Earth Diagnostics 18F-rhPSMA-7.3 PET imaging may be clinically useful in the management of men affected by prostate cancer across the care continuum. The NDA acceptance is supported by clinical data from one prospective phase one study and two prospective phase three clinical trials. The LIGHTHOUSE trial (phase 1) studied safety and diagnostic performance in men with newly diagnosed prostate cancer in 356 patients. In the SPOTLIGHT trial (phase 3), 391 men were evaluated when using 18F-rhPSMA-7.3. The phase three trial was aimed towards men with suspected prostate cancer recurrence based on elevated PSA levels.

“This event marks a significant milestone in advancing our robust prostate cancer portfolio, and we are very pleased that the FDA has accepted our NDA submission for the use of 18F-rhPSMA-7.3 PET imaging in prostate cancer patients,” said David E. Gauden, D.Phil., CEO of Blue Earth Diagnostics. “We look forward to working with the agency throughout the review process, with the goal of having an approved product that is widely available and accessible across the United States. Subject to FDA approval, we believe that 18F-rhPSMA-7.3 PET imaging may be clinically useful in the management of men affected by prostate cancer across the care continuum. All of us at Blue Earth want to express our sincere gratitude to the many patients, physicians, clinical trial sites and collaborators who have worked closely with us to progress 18F-rhPSMA-7.3, and to having successfully completed our phase 3 clinical trials despite all the challenges presented by the COVID-19 pandemic.”

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

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