Lantheus Holdings and GE HealthCare announced an exclusive licensing agreement on September 24, 2025, positioning GE HealthCare to develop, manufacture, and commercialize Lantheus' piflufolastat F18 (marketed as PYLARIFY in the U.S.) in Japan for prostate cancer diagnostics and companion diagnostic applications. The partnership targets Japan's substantial prostate cancer market, where the disease represents the fourth most common cancer worldwide, with Japan recording the third highest number of cases globally in 2022, following the U.S. and China.
Strategic Partnership Leverages Regional Expertise
The collaboration builds on GE HealthCare's March 2025 acquisition of Nihon Medi-Physics Co., Ltd. (NMP), a leading radiopharmaceutical company in Japan. This acquisition provides GE HealthCare with an extensive manufacturing network and specialized R&D expertise in the Japanese market, creating a foundation for the successful introduction of advanced PET imaging technologies.
"This partnership is expected to meaningfully extend the reach of our diagnostic imaging agent in key international markets," said Brian Markison, CEO of Lantheus. "GE HealthCare and NMP's deep regional expertise will enable us to advance the detection and care of prostate cancer and drive significant impact in an important market."
The agreement encompasses the transfer of regulatory dossiers, manufacturing competencies, and technical support to enable GE HealthCare to drive clinical development in Japan toward potential regulatory submissions and commercial launch.
Proven Diagnostic Performance
PYLARIFY (piflufolastat F18) represents a fluorinated small molecule PSMA-targeted PET imaging agent that enables visualization of lymph nodes, bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer. The agent combines PET imaging accuracy with PSMA targeting precision and F18 radioisotope clarity for enhanced diagnostic performance.
The diagnostic agent achieved FDA approval in 2021 and has established itself as the number one utilized PSMA PET imaging agent in the United States. Real-world experience includes over 500,000 scans performed across 48 states, demonstrating substantial clinical adoption and proven diagnostic utility. In 2023, the agent received approval in the European Union, where it is marketed as PYLCLARI through a licensing agreement with Curium.
Clinical Applications and Dosing
PYLARIFY is indicated for positron emission tomography of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer, specifically for patients with suspected metastasis who are candidates for initial definitive therapy and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.
The recommended dosing regimen involves 333 MBq (9 mCi) with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10 mCi), administered as a bolus intravenous injection. Clinical studies have demonstrated that the most frequently reported adverse reactions include headaches, dysgeusia, and fatigue, occurring at rates of ≤2%.
Financial Terms and Governance
Under the licensing agreement terms, GE HealthCare will provide Lantheus with an upfront license fee, development milestones, and tiered royalties based on product sales in Japan. The companies will establish a Joint Steering Committee to oversee development and commercialization activities, ensuring coordinated execution of the partnership objectives.
Kevin O'Neill, President & CEO of the Pharmaceutical Diagnostics segment of GE HealthCare and President of NMP, emphasized the strategic significance: "This collaboration represents a strategic advancement for GE HealthCare as we expand our pipeline of radiopharmaceuticals and continue to deliver on our commitment to improving patient access to innovative diagnostics."
Addressing Clinical Needs
Jean-Claude Provost, Chief Science Officer at Lantheus, highlighted the clinical impact potential: "By aligning with GE HealthCare, we're addressing a critical clinical need in Japan, and helping to lay the foundation for a more personalized approach to prostate cancer detection, diagnosis and monitoring."
The partnership addresses important clinical considerations, including the agent's performance characteristics. PYLARIFY imaging performance for patients with biochemical evidence of prostate cancer recurrence appears to be affected by serum PSA levels, while performance for imaging metastatic pelvic lymph nodes prior to initial definitive therapy seems to be influenced by risk factors such as Gleason score and tumor stage.
