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A recently expanded prostate cancer medication presents newfound hope for patients battling an aggressive form of the disease.
On March 28, Novartis, a Swiss pharmaceutical company, announced that the U.S. Food and Drug Administration has broadened the approval of Pluvicto, a targeted radioligand therapy intended for use prior to chemotherapy.
This innovative therapy, known as RLT, employs a form of targeted nuclear medicine that doctors utilize to combat various types of cancer.
Targeted Treatment for Metastatic Cancer
The drug is specifically designed for individuals diagnosed with PSMA-positive metastatic castration-resistant prostate cancer, commonly referred to as mCRPC. This form of cancer has proven resistant to standard hormone therapies and typically follows one earlier treatment with androgen receptor pathway inhibitors, commonly known as ARPIs.
Originally approved by the FDA on March 23, 2022, the recent expansion triples the number of patients eligible to receive this important treatment, according to a Novartis press release.
Pluvicto is delivered intravenously, allowing it to directly target prostate cancer cells, inhibiting their ability to replicate or leading to their destruction.
A Promising Shift in Treatment Options
Dr. Michael Morris, an expert at Memorial Sloan Kettering Cancer Center in New York, emphasized the significance of this approval for the treatment landscape of mCRPC. He remarked, “The earlier indication for Pluvicto could truly alter our treatment paradigms for patients with this challenging cancer. By offering a targeted therapy, we can better postpone the progression of the disease compared to the second ARPI.”
He underscored that this approval marks a substantial advancement, paving the way for a treatment option that clearly presents clinical benefits for patients who have already undergone one ARPI without receiving chemotherapy.
mCRPC occurs when prostate cancer has metastasized, affecting other body parts and becoming resistant to conventional hormone therapies. Notably, this type of cancer displays elevated levels of prostate-specific membrane antigen, or PSMA, a protein commonly produced by cancer cells.
Clinical Success Rates
Studies indicate that Pluvicto achieved a significant reduction in progression or mortality risk by 59% among patients with mCRPC, as reported by Novartis.
Dr. Jorge A. Garcia, a leading cancer specialist at University Hospitals Seidman Cancer Center, highlighted the transformative nature of this treatment’s approval, stating, “The FDA’s expanded endorsement for lutetium Lu 177 vipivotide tetraxetan signifies a pivotal evolution in the treatment of mCRPC. It underscores the increasing influence of precision oncology initiatives.”
He further noted that providing access to this targeted therapy before chemotherapy not only diversifies treatment alternatives but also reestablishes the standard of care for patients dealing with PSMA-positive cancer.
Prostate Cancer Statistics
Prostate cancer ranks as the second leading cause of cancer deaths among men, with mCRPC contributing to a majority of fatalities. Approximately 20% of all metastatic cases are attributed to this aggressive cancer type.
Research indicates that between 10% and 20% of patients with prostate cancer progress to mCRPC within five years following initial treatment. Additionally, the incidence of metastatic cases has risen annually by 4% to 5% since 2011.
Those at higher risk include men aged 65 and older, as statistics from the American Cancer Society reveal that this age group accounts for 60% of all prostate cancer diagnoses. The likelihood of developing metastatic prostate cancer generally increases between the ages of 65 and 74.
Managing Treatment Side Effects
While Pluvicto presents new therapeutic options, it is essential to address the potential side effects associated with the treatment. Registered data indicates that symptoms may include dry mouth in 61% of patients, fatigue in 53%, nausea in 32%, and constipation affecting 22% of those undergoing therapy.
Importantly, patients have been able to continue with chemotherapy treatments following their administration of Pluvicto.
Future Research and Treatment Approaches
In its commitment to furthering the capabilities of RLT, Novartis has confirmed plans to explore the use of this therapy for additional advanced cancers, such as breast, colon, neuroendocrine, lung, and pancreatic cancers.
The expansion of Pluvicto represents a significant stride toward enhancing treatment options for patients grappling with complex cancer conditions. As precision medicine continues to evolve, patients can look forward to a future with more targeted therapies aimed at improving survival rates and quality of life.
