Novartis Wins FDA Approval For Pluvicto In Earlier Stage Metastatic Prostate Cancer, Expanding Patient Access

Novartis has received approval from the U.S. Food and Drug Administration (FDA) for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in combination with an androgen receptor pathway inhibitor (ARPI) for the treatment of adults with prostate-specific membrane antigen (PSMA)-positive metastatic hormone-sensitive prostate cancer (mHSPC). The approval allows Pluvicto to be used earlier in the course of the disease, alongside standard treatment that includes an ARPI and androgen deprivation therapy (ADT), expanding treatment options for patients with advanced prostate cancer.

The FDA's decision is based on results from the Phase III PSMAddition trial, which demonstrated that adding Pluvicto to the current standard of care reduced the risk of disease progression or death by 28% compared with standard treatment alone. An updated analysis showed an even greater benefit, with a 33% reduction in the risk of progression or death. The study also reported a positive trend toward improved overall survival, although the final overall survival analysis is still ongoing as the data continue to mature.

According to Dr. Michael Morris, Prostate Cancer Section Head in Genitourinary Oncology at Memorial Sloan Kettering Cancer Center and a principal investigator of the U.S. study, the approval reflects the growing importance of treating metastatic hormone-sensitive prostate cancer more aggressively at an earlier stage. He said the availability of a radioligand therapy like Pluvicto at this point in treatment significantly expands physicians' options and represents meaningful progress for patients.

With this expanded indication, Pluvicto can now be used across all stages of PSMA-positive metastatic prostate cancer, nearly doubling the number of patients eligible for the therapy. The treatment was previously approved for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). Globally, more than 186,000 men are diagnosed with metastatic hormone-sensitive prostate cancer each year. Despite advances in treatment, many patients continue to experience disease progression, with nearly one-third failing to achieve undetectable PSA levels on current doublet therapy and around half progressing to castration-resistant disease within 20 months. More than 80% of prostate cancer patients are estimated to express the PSMA biomarker, making them potential candidates for targeted radioligand therapy.

Gina Carithers, President and CEO of the Prostate Cancer Foundation, described the approval as an important milestone that signals a shift toward earlier and more precise treatment of metastatic prostate cancer. She said the expanded approval gives patients access to a targeted treatment option from the time of their metastatic diagnosis, helping redefine the standard of care.

The safety profile of Pluvicto in the PSMAddition study was consistent with previous clinical trials, including PSMAfore and VISION. Grade 3 or higher adverse events were reported in 50.7% of patients receiving Pluvicto plus standard therapy, compared with 43.0% of those receiving standard treatment alone. The most commonly reported side effects included dry mouth, fatigue, nausea, hot flushes, and anemia. Researchers also found that patients' health-related quality of life remained generally consistent throughout treatment.

Commenting on the approval, Victor Bultó, President of Novartis US, said the expanded indication nearly doubles the number of patients who could benefit from Pluvicto. He added that patients with metastatic prostate cancer continue to face significant unmet medical needs, making it important to introduce precision therapies earlier in the treatment journey. Bultó also emphasized that Novartis' continued investment in radioligand therapy research and infrastructure will help bring these innovative treatments to a broader patient population.