New Treatment Option for Prostate Cancer Patients: POSLUMA® (Flotufolastat F 18) Injection Included in NCCN Guidelines® by Blue Earth Diagnostics

Blue Earth Diagnostics, a renowned company in the development and commercialization of innovative PET radiopharmaceuticals, is delighted to announce that its POSLUMA® (flotufolastat F 18) injection, an optimized, high-affinity radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted PET imaging agent, is now part of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Prostate Cancer version 2.2023.

Indicated for positron emission tomography (PET) of PSMA positive lesions in men with prostate cancer who are candidates for initial definitive therapy or suspected recurrence based on elevated serum PSAs, POSLUMA has been included alongside and for all the same categories as other FDA-approved PSMA PET agents. The NCCN Guidelines are designed to aid physicians, medical staff, payers, patients, and their families in taking on cancer care in order to achieve improved patient care and outcomes.

POSLUMA has made history! On May 25, 2023, it became the first and only imaging agent to have the stamp of approval from the U.S. Food and Drug Administration (FDA). This revolutionary product is developed with proprietary radiohybrid (rh) technology and is specifically designed to target PSMA.

It has quickly become widely available through the national network of 36 radiopharmacies of Blue Earth Diagnostics’ commercial U.S. manufacturer and distributor. Get your hands on this cutting-edge discovery today and take advantage of the incredible imaging capabilities!

Blue Earth Diagnostics is delighted to announce that POSLUMA has been included in the esteemed National Comprehensive Cancer Network (NCCN) Guidelines. This monumental milestone further highlights the clinical utility of POSLUMA when used to diagnose and treat patients with newly diagnosed or recurrent prostate cancer, and can increase patient access to the new product.

With the commitment to increase U.S. commercial supply, Blue Earth Diagnostics is dedicated to making POSLUMA available to everyone. David E. Gauden, D. Phil, Chief Executive Officer of the Company, expressed his enthusiasm, “The addition of POSLUMA to the highly respected NCCN Guidelines is a major milestone for Blue Earth Diagnostics.

We believe it further validates the clinical utility of POSLUMA in patients with newly diagnosed or recurrent prostate cancer, and can help expand patient access.”

Physicians and healthcare providers rely heavily on the NCCN Guidelines as a benchmark to determine healthcare utility. With that in mind, Blue Earth Diagnostics developed POSLUMA to help them detect and localize prostate cancer. This update recognizes the crucial ability of PSMA PET imaging procedures to detect and localize both newly diagnosed and biochemically recurrent cases of prostate cancer, which is pivotal in choosing the right treatment option for each patient.

The NCCN panel, an esteemed collection of medical professionals from multiple fields of expertise, recently conducted a rigorous review of the newly-approved POSLUMA drug – and the findings were remarkable. The review leaned heavily on the evidence presented by the U.S. FDA during its approval, as well as expansive results from Phase 3 clinical trial publications in the Journal of Urology and European Urology.

The National Comprehensive Cancer Network® (NCCN®) is a not-for-profit alliance with an inspiring mission: to improve and facilitate cancer care to ensure better lives for patients everywhere.

For over two decades, the leading cancer centers within the NCCN have been devoted to providing quality care, conducting groundbreaking research, and spreading educational resources to support patient care. Through its efforts, NCCN is committed to promoting equality and accessibility in cancer care for all.

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) are the go-to source for trusted, evidence-based advice when it comes to cancer care. They provide concise, effective recommendations for cancer treatment, prevention, and supportive services that have been vetted by leading experts in the field.

With a commitment to continuous updates and transparent policy, the NCCN Guidelines® represent the gold standard for cancer management and serve as the perfect reference for clinicians and patients alike.

About POSLUMA® (flotufolastat F 18)

POSLUMA® (flotufolastat F 18) injection has revolutionized the diagnostic imaging of prostate-specific membrane antigen (PSMA), enabling precision PET imaging to determine the location and extent of prostate cancer. This optimized, targeted radiohybrid imaging agent helps to guide clinical management, offering useful insights to doctors and patients alike.

Approved in May 2023 by the U.S. Food & Drug Administration, POSLUMA is labeled with the radioisotope 18F for patient accessibility and longer-lasting image quality, while its novel radiohybrid technology gives it unrivaled affinity for the PSMA-positive lesions associated with prostate cancer. With POSLUMA, doctors and patients now have the power to detect and assess prostate cancer more accurately and effectively than ever before.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

Blue Earth Diagnostics is at the forefront of revolutionary prostate cancer treatment technology, having acquired exclusive, worldwide rights to develop, market, and distribute the radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds.

Developed at the Technical University of Munich in Germany, these compounds attach to and are internalized by prostate cancer cells and can be radiolabeled with a variety of imaging and therapeutic isotopes to create a true theranostic solution.

The diagnostic application of rhPSMA was approved by the U.S. Food and Drug Administration in 2023, and its potential therapeutic use is under development with its sister company Blue Earth Therapeutics.

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds offer a groundbreaking theranostic technology, combining traditional imaging and therapeutic approaches to diagnose and treat prostate cancer.

Originating from Technical University of Munich, this technology has been adopted by Blue Earth Diagnostics, who in 2018 acquired exclusive, worldwide rights to rhPSMA diagnostic imaging and therapeutic rights in 2020, and sublicensed the therapeutic application to Blue Earth Therapeutics.

The positive results of this technology have recently been granted U.S. Food and Drug Administration approval and is now available as a radiohybrid PET diagnostic imaging product, offering a remarkable progress in prostate cancer management.

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