FDA Accepts NDA for New Formulation of PSMA PET Injection in Prostate Cancer
The new formulation should increase the batch size by approximately 50% and will offer the potential to expand access to patients in new geographic locations.
The new formulation should increase the batch size by approximately 50% and will offer the potential to expand access to patients in new geographic locations.
The FDA has accepted a new drug application (NDA) for a new formulation of the piflufolastat F 18 injection, a prostate-specific membrane antigen (PSMA) PET imaging agent, according to a press release from the developer, Lantheus Holdings.1
The FDA has set a Prescription Drug User Fee Act Date of March 6, 2026.
As noted in the release, the acceptance of the NDA builds upon the success and efficacy of piflufolastat F 18 (18F-DCFPyL; Pylarify), which has shown high levels of diagnostic performance and meaningful impact on clinical decision making.
The new formulation is anticipated to improve the manufacturing process and increase the batch size by around 50%; it will also increase the radioactive concentration of the agent and has the potential to expand patient access in different geographic locations.
In the multicenter, phase 3 CONDOR trial (NCT03739684), the 18F-DCFPyL-PET/CT agent demonstrated a median true-positive rate of 86% based on 3 independent readers.2 Reader 1 found a correct localization rate (CLR) of 85.6% (95% CI, 78.8%-92.3%); reader 2 observed a CLR of 87.0% (95% CI, 80.4%-9.6%); and reader 3 observed a CLR of 84.8% (95% CI, 77.8%-91.9%).
Currently, 18F-DCFPyL is indicated for use as a radioactive diagnostic agent for PET of PSMA-positive lesions in patients with prostate cancer with suspected metastasis who are candidates for initial definitive therapy and with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
“We are pleased the FDA accepted Aphelion’s NDA for the new piflufolastat F 18 formulation, which we expect will improve patient access due to a significant increase in the number of doses per batch,” Brian Markison, chief executive officer of Lantheus, stated the press release.1 “This formulation is a natural next step in our commitment to advancing PSMA imaging. There is a growing burden of prostate cancer in the US and a clear need for accurate and early detection. Building on [18F-DCFPyL] proven performance and accuracy, Lantheus is well-positioned for continued leadership in prostate cancer imaging.”
The recommended dose of 18F-DCFPyL is 333 MBq (9 mCi), with an acceptable range of 296 MBq to 370 MBq (8 mCi to 10mCI), via bolus intravenous injection.
18F-DCFPyL has no contraindications. The label states that imaging interpretation errors can occur with the agent; a negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. PSA levels do affect the performance of the agent for patients with biochemical evidence of recurrence of prostate cancer; Gleason score and tumor stage affect the performance for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy.
The most frequently reported adverse reactions with 18F-DCFPyL were headaches, dysgeusia, and fatigue, all of which occurred at a rate of 2% or less in clinical studies; a delayed hypersensitivity reaction was observed in 1 patient with a history of allergic reactions.
In the CONDOR trial, 14 patients (6.7%) experienced an adverse effect (AE); the most frequent were headache (1.9%), fatigue (1.0%), and hypertension (1.0%). One patient with a history of allergic reactions had a serious grade 3 AE. There were no grade 4 events reported, and no deaths occurred.
“We have reached a key milestone and delivered on our commitment to advance prostate cancer imaging through sustainable innovation. By enhancing the efficiency of production, we expect to improve patient access, streamline operations, and support the broader healthcare system’s ability to deliver timely diagnostic imaging,” Paul Blanchfield, president of Lantheus, said in the release.1
References
- Lantheus announces FDA acceptance of NDA for new formulation for market-leading PSMA PET imaging agent. News release. Lantheus Holdings. August 6, 2025. Accessed August 7, 2025. https://tinyurl.com/mu6nenav
- Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic performance of 18F-DCFPyL-PET/CT in men with biochemically recurrent prostate cancer: results from the CONDOR phase III, multicenter study. Clin Cancer Res. 2021;27(13):3674-3682. doi:10.1158/1078-0432.CCR-20-4573
