NDA for PSMA-Targeted PET Imaging Agent 18F-rhPSMA-7.3 in Prostate Cancer Accepted by FDA

A new drug application for 18F-rhPSMA-7.3 was accepted by the FDA to help with diagnostic imaging in prostate cancer.

The FDA has accepted a new drug application (NDA) for 18F-rhPSMA-7.3 (Axumin), an investigational radiohybrid PET imaging agent targeting prostate-specific membrane antigen (PSMA), according to a press release from Blue Earth Diagnostics.1

The agent is intended to help with prostate cancer diagnostic imaging. The application is supported by several clinical trials, including the phase 3 LIGHTHOUSE trial (NCT04186819) which assessed the diagnostic performance of 18F-rhPSMA-7.3 PET in newly diagnosed prostate cancer. Findings from the trial, which included a total of 356 participants, are due to be presented at an upcoming medical conference.

The agent was also assessed as part of the phase 3 SPOTLIGHT trial (NCT04186845) in a population of patients with suspected biochemical recurrence.2 The study included a total of 391 patients. Results from the study, which were presented at the 2022 Society of Nuclear Medicine & Molecular Imaging Annual Meeting, highlighted a high level of inter- and intra-reader agreement in the pelvic lymph node region, with a concordance of 87% reported for 3 blinded independent central PET readers.

“This event marks a significant milestone in advancing our robust prostate cancer portfolio and we are very pleased that the FDA has accepted our NDA submission for the use of 18F-rhPSMA-7.3 PET imaging in prostate cancer patients,” David E. Gauden, DPhil, chief executive officer at Blue Earth Diagnostics, said in the press release. “We look forward to working with the agency throughout the review process, with the goal of having an approved product that is widely available and accessible across the United States. Subject to FDA approval, we believe that 18F-rhPSMA-7.3 PET imaging may be clinically useful in the management of men affected by prostate cancer across the care continuum.”

The primary end points of the LIGHTHOUSE trial are sensitivity and specificity of 18F-rhPSMA-7.3, with key secondary outcomes including inter- and intra-reader agreement and treatment-released adverse effects (TRAEs). To enroll, patients were required to be over 18 years of age with histologically confirmed prostate adenocarcinoma. Patients were also required to undergo elective radical prostatectomy with pelvic lymph node dissection.

In the SPOTLIGHT trial, the primary outcome measure was positive predictive value and secondary outcomes included inter- and intra-reader agreement and TRAEs. Patients needed to be over 18 years old with a history of localized prostate adenocarcinoma and previous curative intent treatment. Elevated prostate-specific antigen levels indicative of biochemically recurrent disease and eligibility for curative intent salvage therapy were required.

“Prostate cancer is a leading cause of male cancer–related death worldwide, and accurate localization and staging of the disease is critical in establishing optimal medical management strategies,” Eugene Teoh, MBBS, DPhil, MRCP, FRCR, chief medical officer at Blue Earth Diagnostics, concluded. “We believe that the performance of 18F-rhPSMA-7.3, its high PSMA binding affinity and potential for low bladder activity will make it a valuable diagnostic tool that is radiolabeled with 18F for high image quality and readily available patient access.”

References

  1. Blue Earth Diagnostics announces FDA acceptance of new drug application for 18F-rhPSMA-7.3, a radiohybrid prostate-specific membrane antigen-targeted PET imaging agent for prostate cancer. News release. September 27, 2022. Accessed September 28, 2022. https://bwnews.pr/3UKgAo2
  2. Kuo K, Esposito G, Yoo D, Zukotynski K. Inter- and intra-reader reproducibility of 18F-rhPSMA-7.3 PET image interpretation in patients with suspected prostate cancer recurrence: results from a phase 3, prospective, multicenter study (SPOTLIGHT). J Nucl Med. 2022;63(suppl 2):2539. https://jnm.snmjournals.org/content/63/supplement_2/2539