Flotufolastat F 18 now available in the US for use in the management of prostate cancer
Flotufolastat F 18 was granted FDA approval on May 25, 2023 based on data from the phase 3 SPOTLIGHT and LIGHTHOUSE trials.
Flotufolastat F 18 (formerly 18F-rhPSMA-7.3; trade name, Posluma), a high-affinity radiohybrid prostate-specific membrane antigen (PSMA)-targeted PET imaging agent, is now commercially available in the United States for use in the management of prostate cancer, announced Blue Earth Diagnostics and PETNET Solutions, Inc., in a news release.1
"We are pleased to make POSLUMA widely available across the United States for use in men with newly diagnosed or suspected recurrence of prostate cancer," says David E. Gauden, D.Phil.
“We are pleased to make POSLUMA widely available across the United States for use in men with newly diagnosed or suspected recurrence of prostate cancer, and hope that this will make a real difference to physicians and their patients. Our product introduction plan for POSLUMA includes practical education programs for physicians and staff at imaging centers to educate them on the appropriate use of POSLUMA, including image acquisition and reader training programs to help ensure the best information is available to inform patient care. In addition, we are actively communicating with Medicare carriers, Medicare Advantage Plans, private insurers and radiology benefit managers to help them understand the utility and value of POSLUMA, so that they will cover these procedures appropriately,” said Chief Executive Officer of Blue Earth Diagnostics Ltd, David E. Gauden, D.Phil., in the news release.
Flotufolastat F 18 injection is indicated for PET imaging of PSMA-positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level. The agent was granted FDA approval on May 25, 2023 on the basis of data from the phase 3 SPOTLIGHT2 and LIGHTHOUSE3 trials.
By the end of June, 31 PETNET radiopharmacies will be engaged in commercial production of flotufolastat across the United States. Additional sites will begin manufacturing the radiopharmaceutical by the end of the summer.
Phase 3 data on flotufolastat F 18
Updated data from the phase 3 SPOTLIGHT trial (NCT04186845) were presented at the American Urological Association 2023 Annual Meeting and showed that PET imaging with 18F-rhPSMA-7.3 frequently led to post-scan disease upstaging in men with prostate cancer recurrence compared with baseline conventional imaging.2
In total, 18F-rhPSMA-7.3 showed a correct detection rate (CDR) between 45% and 47% in 250 of 366 men who had negative baseline conventional imaging. CDR was defined as the percentage of patients scanned with at least 1 true positive PET finding compared with the Standard of Truth of histopathology or confirmatory conventional imaging. Upstaging results were found to vary depending on prior treatment and anatomical region.
Initial data from the phase 3 LIGHTHOUSE trial (NCT04186819) were presented at the 2022 Society of Urologic Oncology Annual Meeting and showed that use of 18F-rHPSMA-7.3 PET prior to prostatectomy was associated with positive disease detection.3
According to 3 readers, 7.8% to 13.0% of patients (n = 296) had a 18F-rHPSMA-7.3 PET–positive pelvic lymph node. Extrapelvic lesions were also identified in 16% to 28% of patients in an extended population (n = 352) that included those who received 18F-rHPSMA-7.3 PET regardless of surgery.
The safety of flotufolastat F 18 was evaluated in a population of 747 patients with initial or recurrent prostate cancer enrolled across clinical trials. The most common adverse effects were diarrhea, blood pressure increase, and injection site pain, which were reported in at least .4% of patients.
References
1. Blue Earth Diagnostics and PETNET Solutions Inc, a Siemens Healthineers Company, announce U.S. commercial availability of POSLUMA® (Flotufolastat F 18) injection for PET imaging of prostate cancer. News release. June 21, 2023. Accessed June 22, 2023. https://www.businesswire.com/news/home/20230621660976/en/Blue-Earth-Diagnostics-and-PETNET-Solutions-Inc-A-Siemens-Healthineers-Company-Announce-U.S.-Commercial-Availability-of-POSLUMA
2. Schuster DM. Detection rate of 18F-rhPSMA-7.3 PET in patients with suspected prostate cancer recurrence: results from a phase 3, prospective, multicenter study (SPOTLIGHT). J Clin Oncol. 2022(suppl 6):9. doi:10.1200/JCO.2022.40.6_suppl.009
3. Chapin BF. Diagnostic performance and safety of 18F-rhPSMA-7.3 PET in patients with newly diagnosed prostate cancer: results from a phase 3, prospective, multicenter study (LIGHTHOUSE). Poster presented at Society for Urologic Oncology (SUO) 23rd Annual Meeting; November 30-December 2, 2022; San Diego, CA. Poster 134
Dr. Schuster highlights the FDA approval of imaging agent flotufolastat F 18 in prostate cancer
June 22nd 2023"We're excited that the FDA approval of this radiotracer gives us yet more tools at our disposal to diagnose prostate cancer in all its forms, from early to late in the disease process," says David M. Schuster, MD, FACR.
