FDA Approves Pylarify TruVu to Expand Access to PSMA PET Imaging for Prostate Cancer
Published: 16 Mar 2026
Author: Precedence Research
New formulation expected to improve production capacity and availability of advanced diagnostic scans
The U.S. Food and Drug Administration (FDA) has approved Pylarify TruVu (piflufolastat F 18), a new formulation of an established prostate cancer imaging agent designed to enhance production efficiency and expand patient access to prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans. The announcement was made by Lantheus Holdings, Inc., the manufacturer of the Pylarify imaging agent.
Pylarify TruVu maintains the same diagnostic performance as the original Pylarify formulation but introduces improvements in manufacturing flexibility. The updated formulation allows higher radioactive concentrations during production, enabling manufacturers to create larger batches of the radiotracer used in PET imaging. This capability is expected to help imaging providers supply more doses to hospitals and diagnostic centers, potentially allowing more patients to receive advanced prostate cancer imaging.
Improving manufacturing and distribution efficiency
The FDA approval of Pylarify TruVu primarily focuses on increasing manufacturing efficiency and distribution capacity. Radiopharmaceuticals used in PET imaging have a limited shelf life because the radioactive components decay over time. As a result, they must be produced and delivered quickly to imaging facilities. By allowing higher concentration batches, the new formulation could enable producers to distribute larger quantities of the tracer within the same production cycle.
This improvement may significantly increase access to PSMA PET scans, particularly in regions where availability has been limited due to supply constraints. With greater production capacity, imaging providers may be able to deliver more doses to hospitals and diagnostic centers, improving patient access to timely and accurate cancer imaging.
Lantheus expects Pylarify TruVu to launch in the United States in the fourth quarter of 2026, aligning with new reimbursement codes scheduled to take effect in October of the same year. These reimbursement updates may provide clearer guidance for healthcare providers seeking insurance coverage for PSMA PET imaging procedures.
Market outlook for PET imaging technologies
According to Precedence Research, the positron emission tomography (PET) market size is estimated at USD 2.96 billion in 2025 and is projected to surpass around USD 5.69 billion by 2035, expanding at a CAGR of 6.75% between 2026 and 2035. The growth of the market is being driven by rising cancer prevalence, increasing adoption of advanced imaging technologies, and ongoing development of novel radiopharmaceuticals designed to improve diagnostic accuracy and patient outcomes.
With innovations such as Pylarify TruVu, the PET imaging landscape is expected to continue evolving, offering improved access to advanced diagnostic tools and supporting earlier, more precise detection of cancer worldwide.
Understanding PSMA PET imaging in prostate cancer
PSMA PET imaging plays a critical role in identifying prostate cancer cells throughout the body. The technology targets prostate-specific membrane antigen (PSMA), a protein commonly expressed at high levels on prostate cancer cells. By attaching to these proteins, the radiotracer allows PET imaging systems to detect small cancer lesions that may not be visible through traditional imaging methods such as CT scans or MRI.
When Pylarify is injected into the bloodstream, the tracer binds to PSMA proteins present on prostate cancer cells. PET imaging then detects the radiation signal emitted by the tracer, helping physicians identify cancer sites in lymph nodes, bones, and other tissues. This capability can improve disease detection, especially in patients with suspected metastatic disease or those experiencing rising prostate-specific antigen (PSA) levels following treatment.
Clinical evidence supporting Pylarify imaging agents
The original Pylarify imaging agent received FDA approval in 2021 after clinical trials demonstrated its effectiveness in detecting prostate cancer lesions. Research supporting the agent included the phase 3 OSPREY and CONDOR trials, which evaluated diagnostic accuracy in different patient populations.
In the OSPREY trial, the imaging agent showed strong specificity and positive predictive value compared with conventional imaging techniques such as CT or MRI. The CONDOR study focused on men with biochemical recurrence, where PSA levels rise after initial treatment. Researchers observed high rates of accurate lesion localization, even in patients with relatively low PSA levels.