FDA OKs New Piflufolastat F 18 Formulation for Prostate Cancer Imaging

The FDA has granted approval to a new formulation of piflufolastat F 18 (Pylarify TruVu), a radioactive prostate-specific membrane antigen (PSMA) PET imaging agent, for use in patients with prostate cancer.¹

The new formulation has been optimized for manufacturing and production efficiency. Specifically, it is expected to increase batch size by approximately 50% while delivering high diagnostic performance consistent with the current formulation on the market.² Another key differentiator is the new formulation’s increased radioactivity, which can extend the agent’s shelf life and thereby enable broader patient access.

Now backed by regulatory approval via the 505(b)(2) pathway, the agent is set to further expand accessibility of high-quality PSMA PET imaging to more patients at a comparable level of diagnostic accuracy. The new formulation will be rolled out later this year on a rolling geographic basis.

“As we continue to innovate and expand our portfolio, ensuring a reliable and uninterrupted supply for our customers remains our top priority,” said Dorothy Barr, senior vice president of Manufacturing and Technical Operations at Lantheus, in a news release.¹ “The [new piflufolastat F18] formulation is designed to enhance manufacturing efficiency, strengthen supply chain dependability and ultimately improve the healthcare system’s ability to deliver timely, accurate imaging for people with prostate cancer.”

About Piflufolastat F 18 and Clinical Impact

Approved by the FDA in May 2021, piflufolastat F 18 is indicated for use in men with prostate cancer. The agent is a fluorinated small molecule administered as intravenous injection prior to PET scanning to identify recurrence and/or metastasis. As a radionuclide tracer, the agent achieves this by targeting and binding to the transmembrane protein PSMA, which is overrepresented in prostate cancer cells. Binding to the target enables visualization of prostate cancer cells and detection of PSMA-positive lesions.

The approval was partially supported by the phase 3 CONDOR study (NCT03739684), where the agent demonstrated a high positive predictive value and successfully detected at least 1 lesion in 59% to 66% of patients with prostate cancer biochemical recurrence.³ Longer follow-up of the study showed that the agent was even able to identify lesions in patients with low prostate-specific antigen levels.

In the phase 2/3 OSPREY trial (NCT02981368), the other study supporting approval, the agent exhibited a high median specificity of 97.9% (95% CI, 94.5%–99.4%), median sensitivity of 40.3% (95% CI, 28.1%–52.5%), and median positive and negative predictive values of 86.7% (69.7%–95.3%) and 83.2% (78.2%–88.1%), respectively, among patients with high-risk prostate cancer undergoing radical prostatectomy with pelvic lymphadenectomy.⁴

Since approval, the agent has helped transform the staging and treatment paradigm for recurrent or metastatic prostate cancer, moving away from a cycle of testosterone suppression and chemotherapy to targeted radiation.

“[Piflufolastat F 18] changes the whole paradigm for how we approach patients who have recurrent or metastatic disease,” said Bridget Koontz, MD, AdventHealth Cancer Institute and East Carolina University Brody School of Medicine, in a 2022 interview with Targeted Oncology. “Before, if someone was diagnosed with metastatic prostate cancer, we would put them on medication that took all of their testosterone away, so we medically castrated these men… The advantage of PSMA PET testing and [piflufolastat F 18] is that if we can find their disease when it's just starting to metastasize very early in that process, and they only have a few metastases, we can treat them with targeted radiation. In some cases, instead of going on testosterone suppression, we can target those areas with radiation, put them back into remission, and give them several more years.”

Safety Considerations

The safety profile of the new formulation is also expected to be consistent with the current formulation. According to Koontz, the agent is generally well-tolerated; patients given piflufolastat F 18 typically experience minimal, temporary adverse effects, including headache, fatigue, or dysgeusia.

REFERENCES

1. Lantheus announces FDA approval of PYLARIFY TruVu™ (piflufolastat F 18) injection. News release. Lantheus. March 6, 2026. Accessed March 9, 2026. https://tinyurl.com/ycwm6acv

2. Lantheus announces FDA acceptance of NDA for new formulation for market-leading PSMA PET imaging agent. News release. ‌Lantheus Holdings. August 6, 2025. Accessed December 12, 2025. https://tinyurl.com/bdh8ddt2

3. 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

4. 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. 2021;206(1):52-61. doi:10.1097/JU.0000000000001698