FDA Approves Expanded Label of Novartis’ Prostate Cancer Treatment, Pluvicto
Based on additional results from the Phase III PSMAfore clinical trial, the therapy is now approved for use prior to chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer.
The FDA has approved Novartis’ radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been previously treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy.1
According to Novartis, the expanded label approximately triples the number of patients eligible to receive Pluvicto. This most recent approval is based on results from the Phase III PSMAfore trial in which Pluvicto reduced the risk of radiographic progression or death by 59%. An updated analysis discovered that Pluvicto more than doubled median radiographic progression-free survival (rPFS). The final overall survival analysis numerically favored Pluvicto with a hazard ratio of 0.91, but was deemed to be not statistically significant.
In a press release, Michael Morris, MD, prostate cancer section head, GU Oncology, Memorial Sloan Kettering Cancer Center, and the principal investigator of the study in the US said: "The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI. This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy."
Oliver Sartor, MD, chair of genitourinary cancer disease group and director of radiophar-maceutical clinical trials, Mayo Clinic added: "The clinical development of PSMA-targeting radioligand therapy has provided important insights into the treatment of metastatic castration-resistant prostate cancer. The trial data demonstrated a clear clinical benefit in delaying disease progression in eligible patients, offering an additional therapeutic approach in this setting."
Novartis unveiled initial data from the PSMAfore study in October 2023. The trial met its primary endpoint of rPFS with a HR of 0.41. Additional results showed that patients treated with Pluvicto experienced an improved quality of life, maintaining their FACT-P total score for 3 months longer than a change in ARPI.2
In a press release from the time, Jeff Legos, then executive vice president, global head of oncology development at Novartis said: “These promising results from PSMAfore could change the treatment paradigm for advanced prostate cancer by allowing patients to potentially avoid or delay taxane-based chemotherapy, which carries a heavy burden of side effects. While data collection for overall survival continues, the consistency of the benefit observed on other clinically meaningful efficacy endpoints, together with improved quality of life and favorable safety profile, show the potential of Pluvicto for taxane-naïve patients with mCRPC.”
References
1. FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer. News release. Novartis. March 28, 2025. Accessed March 28, 2025. https://www.prnewswire.com/news-releases/fda-approves-novartis-radioligand-therapy-pluvicto-for-earlier-use-before-chemotherapy-in-psma-positive-metastatic-castration-resistant-prostate-cancer-302414516.html
2. Novartis Pluvicto™ shows clinically meaningful and highly statistically significant rPFS benefit in patients with PSMA-positive metastatic castration-resistant prostate cancer in the pre-taxane setting. News release. Novartis. October 23, 2023. Accessed March 28, 2025. https://www.novartis.com/news/media-releases/novartis-pluvictotm-shows-clinically-meaningful-and-highly-statistically-significant-rpfs-benefit-patients-psma-positive-metastatic-castration-resistant-prostate-cancer-pre-taxane-setting
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