FDA approves new radioligand therapy for PSMA positive metastatic prostate cancer
The U.S. Food and Drug Administration (FDA) has approved a new radiopharmaceutical therapy for the treatment of metastatic prostate cancer.
The approval of Pluvicto, which is manufactured by Novartis, was announced Wednesday, March 23. Pluvicto is the first FDA-approved targeted radioligand therapy for metastatic castration-resistant prostate cancer (mCRPC).
“Prostate cancer is the second leading cause of cancer-related death in Americans with a prostate gland. Although the treatment landscape for mCRPC continues to evolve, there is a high unmet need for additional precision medicine treatment options to improve outcomes for these patients,” said Jamie Bearse, CEO and President at ZERO – The End of Prostate Cancer. “The approval of Pluvicto offers new hope to the mCRPC community.”
This is positive news for patients with PSMA positive metastatic prostate cancer who have not responded to other lines of therapy as the treatment has been shown to improve overall survival rates in clinical trials. Researchers conducting the trial observed that patients who were treated with Pluvicto in addition to standard prostate cancer care had a 38% reduction in risk of death, as well as a significant decrease in risk of disease progression.
On March 23, the FDA also approved Locametz, which is an imaging agent that can be used to highlight PSMA positive lesions on PET scans. This, in turn, identifies patients who might be eligible for targeted treatment with Pluvicto.
In response to the approval, the Society of Nuclear Medicine and Molecular Imaging (SNMMI) released a statement applauding the decision.
“We are delighted by the FDA approval of this transformational, innovative therapy for men with advanced metastatic castrate resistant prostate cancer,” said SNMMI President Richard L. Wahl, MD. “We are proud of the society members who contributed substantially to this new theranostic paradigm, as well as all of the authors who published articles on this therapy in the Journal of Nuclear Medicine.”
The therapeutic treatment is expected to be available to physicians and patients within weeks.
For more information on the FDA’s approval, visit the Novartis website.
For information on SNMMI’s updated appropriate use criteria for PSMA PET imaging, visit snmmi.org.
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.