A recent FDA approval and impressive phase 3 data shared during the ASCO Annual meeting this week have accelerated the integration of PSMA-based agents into clinical practice.
Last week, the FDA approved the PSMA PET imaging agent 18F-DCFPyL (piflufolastat F 18; Pylarify) for identifying suspected metastasis or recurrence of prostate cancer. Piflufolastat F 18 became the second PSMA PET imaging agents approved in prostate cancer, following Ga 68 PSMA-11.
Pivotal data from the phase 3 VISION trial shared during ASCO showed that adding the PSMA-targeted therapy 177Lu-PSMA-617 (LuPSMA) to standard of care led to a nearly 40% reduction in the risk of death in patients with PSMA-positive metastatic castration-resistant prostate cancer. Novartis, the manufacturer of LuPSMA, plans to submit these data to the FDA. If approved, LuPSMA would then become the first PSMA theranostic approved in prostate cancer.
Amid these key PSMA research advances, industry activity has heated up this week. Here are 3 developments of note.
Lantheus, the developer of piflufolastat F 18, selected oncology provider GenesisCare to administer the first commercially available dose of piflufolastat F 18.1
Piflufolastat F 18 was approved based on findings from the CONDOR and OSPREY studies. In the CONDOR study, 63.9% of men with biochemically recurrent prostate cancer who had no evidence of disease on standard-of-care imaging had a change in intended management after their 18F-DCFPyL–PET/CT scan.
"Nuclear medicine, including Pylarify PET imaging, is now a pivotal medical specialty that can transform patients by optimizing treatment selection," Neal D. Shore, MD, US Chief Medical Officer of Surgery and Urology, GenesisCare, stated in a press release. "The approval by the FDA for public use of this PET PSMA imaging agent provides critical accessibility which will improve prostate cancer patient management nationwide," added shore.
Cardinal Health and Telix Pharmaceuticals developed and released a white paper, Moving beyond the Myth: Meeting the growing demand for Ga-68 radiopharmaceuticals.2 The paper was developed to alleviate any production/development concerns regarding gallium-based radiopharmaceuticals, such as the FDA-approved Ga 68 PSMA-11.
“A key to satisfying the demand for this isotope lies in having a robust network of radiopharmacies like Cardinal Health,” Christian Behrenbruch, PhD, CEO of Telix, stated in a press release.
“There is a perception in the industry that supply chain issues may limit the availability of gallium-based radiopharmaceuticals. Whilst this may have been true historically, this is no longer the case. The strength and power of gallium lies in its flexibility, with production by either cyclotron or generator. This offers greater flexibility and opportunity for scale than other purely cyclotron-based isotopes.
“Subject to regulatory approval, we look forward to offering state-of-the-art diagnostic imaging to U.S. men living with prostate cancer, and Cardinal Health’s radiopharmacy network and infrastructure will be vital in facilitating nationwide access,” added Behrenbruch.
Bayer has acquired Noria Therapeutics and PSMA Therapeutics, in order to gain a market share in the PSMA space.3 The acquisition expands Bayer’s prostate cancer portfolio with a differentiated alpha radionuclide therapy based on actinium-225 and a small molecule targeting PSMA.
“Bayer is focused on addressing the various medical needs of cancer patients, providing treatments that improve patient outcomes throughout the different stages of the disease,” Robert LaCaze, head of the Oncology Strategic Business Unit at Bayer, stated in a press release. “This acquisition is another important milestone in enhancing Bayer’s oncology portfolio through both in-house expertise and strategic collaborations and agreements.”
1. Lantheus Selects GenesisCare to Administer First Commercial Dose of PYLARIFY®, the First and Only FDA-Approved PSMA PET Imaging Agent for Men with Prostate Cancer. Published online June 3, 2021. Accessed June 3, 2021. https://prn.to/34MPpQN.
2. Cardinal Health and Telix Launch Gallium Awareness Campaign With Release of White-Paper: “Moving Beyond the Myth.” Published online May 27, 2021. Accessed June 4, 2021. https://bwnews.pr/3vNvn4y.
3. Bayer acquires Noria and PSMA Therapeutics to expand portfolio in prostate cancer. June 3, 2021. Accessed June 4, 2021. https://bit.ly/3cfLd02.