The U.S. Food and Drug Administration has approved a new therapy for treating metastatic, castration-resistant prostate cancer, along with a complementary diagnostic imaging agent, manufacturer Novartis announced Wednesday.
Pluvicto is the first FDA-approved, targeted radioligand therapy for the disease. The agency’s blessing follows years of clinical trials, which determined that the radiopharmaceutical therapy reduced the risk of death by 38% and progression by 60%.
The administration on March 23 also approved Locametz, an agent used to pinpoint PSMA (prostate specific membrane antigen)-positive lesions in adult patients with metastasized cancer via a PET scan. Provider advocates praised the decision Wednesday, calling it “one of the greatest success stories in nuclear medicine history.”
“We are delighted by the FDA approval of this transformational, innovative therapy for men with advanced metastatic castrate resistant prostate cancer,” Society of Nuclear Medicine & Molecular Imaging President Richard Wahl, MD, said in a statement. “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.”
Approval follows a phase 3 clinical trial, which determined that patients who received Pluvicto plus the standard of care had improved overall survival compared to those who did not. About 30% of patients with evaluable disease at baseline demonstrated a response with the therapy plus care, compared to 2% in the control arm that only received standard treatment. Common adverse events included fatigue (43%), dry mouth (39%), nausea (35%), anemia (32%), decreased appetite (21%), and constipation (20%), the manufacturer reported.
Novartis said the drug is expected to hit the market within weeks following the decision. SNMMI, meanwhile, has updated its appropriate use criteria for PSMA PET imaging to include evaluating individuals’ eligibility for the radioligand therapy. It’s also developing resources to educate metastatic castration-resistant prostate cancer patients about this new treatment option. The five-year survival rate for those with this form of the disease is about 30%, compared to 100% for localized prostate cancer.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.