Lantheus and GE HealthCare Strike Deal for Prostate Cancer PET Tracer in Japan

Lantheus has entered into an agreement with GE HealthCare, granting the latter rights to its blockbuster prostate cancer PET imaging agent, Pylarify, in Japan. This strategic move aims to expand the reach of the diagnostic tool in key international markets, leveraging GE HealthCare's recent acquisition of Nihon Medi-Physics (NMP), a leading radiopharmaceutical provider in Japan.

Deal Structure and Market Implications

The agreement between Lantheus and GE HealthCare involves the transfer of regulatory documents and manufacturing specifications for Pylarify. GE HealthCare plans to utilize NMP's established R&D and manufacturing network to develop, produce, and commercialize the diagnostic tracer in Japan. The deal includes an upfront licensing fee, along with milestone and royalty payments to Lantheus, although specific financial terms were not disclosed.

Brian Markison, CEO of Lantheus, emphasized the partnership's potential to "meaningfully extend the reach of our diagnostic imaging agent in key international markets." The collaboration aims to leverage GE HealthCare and NMP's regional expertise to advance prostate cancer detection and care in Japan.

Pylarify's Performance and Market Position

Pylarify, also known as piflufolastat F-18, has established itself as a leading prostate cancer diagnostic tool since its FDA approval in 2021. The fluorine-18 diagnostic tracer targets tumors with high levels of prostate-specific membrane antigen (PSMA), enabling detection of prostate cancer and its metastatic spread to lymph nodes, bones, and other organs.

In 2024, Pylarify achieved blockbuster status, generating over $1 billion in sales. The diagnostic has been used in more than 500,000 scans in the contiguous United States. For the first half of 2025, Pylarify accounted for approximately two-thirds of Lantheus' revenue, contributing $508 million to the company's total revenue of $750 million.

Competitive Landscape and Future Developments

The prostate cancer PET radiotracer market is becoming increasingly competitive, with products like Blue Earth Diagnostics' Posluma and an upcoming copper-isotope-based theranostic from Clarity Pharmaceuticals challenging Pylarify's dominance. In response, Lantheus is taking steps to reinforce Pylarify's clinical differentiation and support its PSMA PET franchise.

Currently, the FDA is reviewing a new formulation of Pylarify that could increase its batch production size by about 50%, with a decision expected by March 2026. In Europe, where the diagnostic is known as Pylclari, distribution rights are held by nuclear medicine provider Curium. Following its European Commission approval in 2023, Pylclari recently received regulatory approval from Swissmedic in Switzerland.