FDA accepts NDA for new formulation of piflufolastat F 18 in prostate cancer

On August 6, 2025, Lantheus announced that the FDA had accepted a new drug application (NDA) seeking approval of a new formulation of their PSMA-PET imaging agent, piflufolastat F 18 (Pylarify; ¹⁸F-DCFPyL) in prostate cancer.¹

The application, which was submitted by Lantheus’ affiliate, Aphelion, has a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2026.

Piflufolstat F 18 injection is currently indicated in the US for PET imaging of PSMA-positive lesions in patients with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, as well as in patients with suspected recurrence based on an elevated serum prostate-specific antigen level. The recommended dose for piflufolastat F 18 is 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.

According to Lantheus, the new formulation of the imaging agent is expected to increase batch size by around 50%. The formulation also “increases the radioactive concentration of the agent and has the potential to expand patient access in new geographic locations,” the company noted.

“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,” said Brian Markison, CEO of Lantheus, in the news release from the company.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 U.S. and a clear need for accurate and early detection. Building on PYLARIFY’s proven performance and accuracy, Lantheus is well-positioned for continued leadership in prostate cancer imaging.”

Data on piflufolastat F 18

Piflufolastat F 18 injection was approved in the US in May 2021² based on data from the phase 3 OSPREY (NCT02981368) and CONDOR (NCT03739684) trials.

In both studies, patients with prostate cancer were given a single dose of piflufolastat F 18.

The OSPREY trial³ enrolled 385 patients who were divided into 2 cohorts: men with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy (cohort A) and men with suspected recurrent/metastatic prostate cancer on conventional imaging (cohort B). The co-primary end points were specificity and sensitivity.

Data from cohort A of the trial showed greater specificity and positive predictive values (PPVs) with piflufolastat F 18 compared with conventional imaging prior to initial therapy. Overall, the median specificity with piflufolastat F 18 was 97.9% (95% CI, 94.5 to 99.4) among 3 readers, compared with 65.1% with CT or MRI. Additionally, the median PPV was 86.7% with piflufolastat F 18, compared with 28.3% with conventional imaging. Sensitivity and negative predictive values showed no significant difference between the 2 arms.

The CONDOR study⁴ enrolled 208 men with a median baseline PSA of 0.8 ng/mL (range, 0.2 to 98.4 ng/mL). The primary end point was correct localization rate, defined as PPV with anatomic lesion colocalization between piflufolastat F 18 and a composite standard of truth.

Findings showed high rates of correct localization and detection with piflufolastat F 18 in patients with biochemically recurrent prostate cancer, including in those with low PSA values. Overall, the correct localization rate ranged from 84.8% to 87.0%. The disease detection rate ranged from 59.1% to 65.9%.

Adverse events from both trials were observed among less than 2% of patients. These included headache, dysgeusia, and fatigue. One patient with a history of allergic reactions also reported experiencing a delayed hypersensitivity reaction to the treatment.

“We have reached a key milestone and delivered on our commitment to advance prostate cancer imaging through sustainable innovation,” concluded Paul Blanchfield, president of Lantheus, in the news release.¹ “By enhancing the efficiency of production, we expect to improve patient access, streamline operations, and support the broader health care system’s ability to deliver timely diagnostic imaging.”

REFERENCES

1. Lantheus announces FDA acceptance of NDA for new formulation for market-leading PSMA PET imaging agent. News release. Lantheus. August 6, 2025. Accessed August 10, 2025. https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-fda-acceptance-nda-new-formulation-market

2. Lantheus received US FDA approval of PYLARIFY (piflufolastat F 18) injection, the first and only commercially available PSMA PET imaging agent for prostate cancer. News release. Lantheus Holdings, Inc. May 27, 2021. Accessed August 10, 2025. https://investor.lantheus.com/news-releases/news-release-details/lantheus-receives-us-fda-approval-pylarifyr-piflufolastat-f-18

3. Pienta KJ, Gorin MA, Rowe SP, et al. A phase 2/3 prospective multicenter study of the diagnostic accuracy of prostate specific membrane antigen PET/CT with 18F-DCFPyL in prostate cancer patients (OSPREY). J Urol. Published online February 26, 2023. Accessed August 10, 2025. doi:10.1097/JU.0000000000001698

4. 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. Published online February 23, 2023. Accessed August 10, 2025. doi:10.1158/1078-0432.CCR-20-4573