FDA Approves Radioactive Treatment for Prostate Cancer
A new treatment option is available for patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC). Novartis announced recently that the U.S. Food and Drug Administration has approved its targeted radioligand therapy Pluvicto.
Novartis announces #FDA approval today of our targeted radioligand therapy for an indication enabling us to reach even more #cancer patients in need. #NovartisNews #reimaginemedicine
— Novartis News (@NovartisNews) March 23, 2022
Dr. Julio Pow-Sang, Genitourinary Oncology Program
“This is a major development because this is a first of its kind treatment for cancer in general and prostate cancer specifically,” said Dr. Julio Pow-Sang, chair of the Genitourinary Oncology Program at Moffitt Cancer Center. “This type of personalized treatment, based on a patient’s PSMA expression receptor, is a very innovative development, especially for those patients who have already undergone treatment with hormonal therapy and chemotherapy with progression of their cancer. These patients now have an opportunity to benefit from something that wasn’t previously available.”
The approval was based on results from the VISION trial, which looked at radioligand therapy 177Lu-PSMA-617 in patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer. Radioligand therapy combines a targeting compound that binds to markers expressed by tumors — in this instance PSMA — with a radioactive isotope that can emit therapeutic radiation to kill cancer cells while limiting damage to the surrounding normal tissue.
“The VISION trial showed significant improvement in overall survival in patients who had otherwise limited treatment options,” said Dr. Ghassan El-Haddad, associate member of the Diagnostic Imaging and Interventional Radiology Department and investigator overseeing the VISION trial at Moffitt. “In the study, adding 177Lu-PSMA-617 to standard of care led to a nearly 40% reduction in the risk of death versus standard of care alone in patients with progressive prostate-specific membrane antigen-positive mCRPC. In addition, it led to a 60% reduction in the risk of progression or death.”
According to El-Haddad, patients who reach this advanced stage usually have very limited therapeutic options. The use of Pluvicto is coupled with a PET imaging agent that detects the PSMA-positive metastatic lesions throughout the body. If patients have PSMA-positive metastatic lesions on PET, then they would be eligible for the therapy. The approval is expected to have a significant clinical impact on the treatment of patients with advanced mCRPC.
“This combination of a radioligand therapy with an imaging biomarker positivity is a great example of precision medicine, or what we call Nuclear Medicine Theranostics,” said El-Haddad. “The Radionuclide Therapy Program at Moffitt was heavily involved in the VISION trial, and we are extremely enthusiastic about this approval since our patients can now have a new very efficient treatment option.”
