Lantheus Holdings has signed an exclusive licensing deal with GE HealthCare to develop, manufacture, and commercialize the PET imaging agent piflufolastat F 18, marketed as PYLARIFY in the U.S., for use in Japan.

The agreement gives GE HealthCare rights to the agent for prostate cancer diagnostics, including its use as a companion diagnostic.

Under the deal, Lantheus will transfer regulatory and technical documentation to GE HealthCare, which will oversee clinical development and eventual regulatory submission in Japan. GE HealthCare will also leverage resources acquired through its March 2025 purchase of Nihon Medi-Physics, a radiopharmaceutical firm based in Japan.
Piflufolastat F 18 is a fluorinated PET imaging agent that targets prostate-specific membrane antigen (PSMA) to detect metastatic or recurrent prostate cancer. It was approved by the FDA in 2021 and is also cleared for use in the EU, where it is marketed under the name PYLCLARI.

GE HealthCare will pay Lantheus an upfront licensing fee, milestone payments tied to development progress, and tiered royalties on future sales in Japan. A joint steering committee will oversee product rollout and development activities.

“This partnership is expected to meaningfully extend the reach of our diagnostic imaging agent in key international markets,” said Brian Markison, CEO of Lantheus.

Kevin O’Neill, president and CEO of GE HealthCare’s pharmaceutical diagnostics segment and head of NMP, called the collaboration a “strategic advancement” and emphasized the potential to improve diagnostic access in Japan.

According to 2022 data, Japan recorded the third-highest number of prostate cancer cases globally, following the U.S. and China.

The recommended dosage for PYLARIFY is 333 MBq (9 mCi), administered as a bolus intravenous injection. The agent has been used in over 500,000 scans across the U.S. since its approval.

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