Blue Earth Diagnostics and PETNET Solutions, a Siemens Healthineers Company, have announced the availability of POSLUMA (Flotufolastat F 18) Injection for PET Imaging of Prostate Cancer in the United States. POSLUMA, an optimized PET imaging agent, targets prostate-specific membrane antigen (PSMA) positive lesions in prostate cancer patients. It is now commercially available in multiple radio pharmacies across the country, with nationwide availability expected by the end of June 2023. The companies will showcase POSLUMA at the Chicago Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting.
Blue Earth Diagnostics and PETNET Solutions Inc., a Siemens Healthineers Company, have announced the commercial availability of POSLUMA (Flotufolastat F 18) Injection for PET Imaging of Prostate Cancer in the United States. POSLUMA is now commercially available in multiple radio pharmacies across the country, with nationwide availability expected by the end of June 2023.
POSLUMA, developed by Blue Earth Diagnostics, a subsidiary of Bracco, is an advanced PET imaging agent designed to target prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. It is indicated for use in patients who are candidates for initial definitive therapy or suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. The U.S. Food and Drug Administration approved POSLUMA on May 25, 2023.
PETNET Solutions, the primary manufacturer and commercial distributor for Blue Earth Diagnostics in the United States, will facilitate the commercial production and distribution of POSLUMA. Initially, the product will be available through multiple radio pharmacies, and by the end of June 2023, manufacturing will be underway at the 31 PETNET radio pharmacies included in the New Drug Application for POSLUMA. This represents a record number of sites authorized for manufacturing radiopharmaceuticals upon its initial FDA approval. Furthermore, additional PETNET sites are expected to commence POSLUMA production before the end of the summer.
David E. Gauden, D.Phil., CEO of Blue Earth Diagnostics Ltd., expressed his satisfaction with the widespread availability of POSLUMA, aiming to make a positive impact on physicians and their patients dealing with newly diagnosed or suspected recurrent prostate cancer. Blue Earth Diagnostics plans to implement practical education programs for healthcare professionals at imaging centers, ensuring appropriate use of POSLUMA through image acquisition and reader training. The company is actively engaging with Medicare carriers, Medicare Advantage Plans, private insurers, and radiology benefit managers to promote the understanding of POSLUMA’s utility and value, facilitating appropriate coverage for these procedures.
Gauden also emphasized the fruitful collaboration between Blue Earth Diagnostics and PETNET Solutions, which began in 2015 with the commercial supply of Axumin (fluciclovine F 18). Both companies share a dedication to PET molecular imaging and providing imaging tools to support prostate cancer management throughout the continuum of care.
Barry Scott, Head of PETNET Solutions Inc., expressed pride in their role as the main manufacturer and distributor of POSLUMA to imaging centers in the United States. Leveraging their extensive network of cyclotron-equipped radio pharmacies, PETNET Solutions aims to ensure broad access to POSLUMA and other innovative PET biomarkers that contribute to precision medicine for healthcare providers nationwide.
Blue Earth Diagnostics and PETNET Solutions invite attendees to visit their exhibit booths at the upcoming Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Chicago from June 24 to 27, 2023. Blue Earth Diagnostics can be found at Booth 6025, and PETNET Solutions at Booth 6075.
