New prostate cancer PET imaging agent officially available for commercial use

A new radiohybrid prostate-specific membrane antigen (PSMA)-targeted PET imaging agent is now officially available for commercial use in the U.S.

Blue Earth Diagnostics, a Bracco company that specializes in PET radiopharmaceuticals, announced the commercial availability of Posluma on June 21. The imaging agent is indicated for men with prostate cancer suspicious for metastases who are also candidates for definitive therapy and for men in whom disease recurrence is suspected based on PSA levels.

Posluma (flotufolastat F 18) received the U.S. Food and Drug Administration’s approval in May 2023. It will be commercially available through one of the 31 radiopharmacies of PETNET Solutions—Blue Earth’s primary manufacturer and commercial distributor in the U.S.

Blue Earth indicates that production of Posluma will begin at those sites by the end of June, with additional sites expected to manufacture the imaging agent by the end of summer.

“We are pleased to make Posluma widely available across the United States for use in men with newly diagnosed or suspected recurrence of prostate cancer, and hope that this will make a real difference to physicians and their patients,” David E. Gauden, chief executive officer of Blue Earth Diagnostics, said in a prepared statement.

Gauden went on to explain that the rollout of the product will include education programs for physicians and imaging staff to inform them on the appropriate use of the agent, including image acquisition and reader training programs. Gauden also shared that Blue Earth is working with Medicare carriers, Medicare Advantage plans and private insurers to inform them on the utility of Posluma and encourage coverage.

Barry Scott, head of PETNET Solutions, also commented on Posluma’s new commercial availability, indicating that the manufacturer is ready to widely distribute the agent.

“With our large national network of cyclotron-equipped radiopharmacies, we are well-positioned to provide broad access to Posluma, as well as a wide range of other novel PET biomarkers that facilitate precision medicine for healthcare providers across the country,” Scott said.

Both Blue Earth Diagnostics and PETNET Solutions will be at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held in Chicago June 24-27 (in booths 6025 and 6075).

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