FDA expands Pluvicto indication for earlier use in patients with prostate cancer
The FDA approved a radioligand therapy for earlier use prior to chemotherapy in patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer, according to a Novartis-issued press release.
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) received an expanded indication, which allows the radioligand therapy to be used after one androgen receptor pathway inhibitor (ARPI), as well as before chemotherapy.
The FDA based the expanded approval on results from the phase 3 PSMAfore trial, which showed that Pluvicto reduced the risk of radiographic progression or death by 59% (HR = 0.41; 95% CI, 0.29-0.56) vs. a change in ARPI in patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following ARPI therapy, according to the release.
In addition, Pluvicto more than doubled median radiographic progression-free survival from 5.6 months to 11.6 months, according to the release.
The final overall survival analysis favored Pluvicto (HR = 0.91; 95% CI, 0.72-1.14), but the results were not deemed statistically significant, according to the release.
"With worsening outcomes after each successive line of treatment, patients with this type of metastatic prostate cancer and their families have long faced limited options and uncertain outcomes," Gina Carithers, CEO and president of the Prostate Cancer Foundation, said in the press release. "The now expanded approval of Pluvicto is an empowering development for the prostate cancer community. We now have more choices earlier in the treatment journey, enabling patients to advocate for their preferences and work with their oncologist or urologist to determine the treatment option that best suits their needs."
The study also revealed that Pluvicto demonstrated a favorable safety profile, with the most commonly reported adverse events including dry mouth, fatigue, nausea and constipation, according to the release.
“Today’s approval for an expanded indication for Pluvicto brings more choice to nearly three times as many patients, enabling us to further establish radioligand therapies as a pillar in cancer care,” Victor Bultó, president of Novartis US, said in the release. “As pioneers in the [radioligand therapy] RLT space, Novartis is committed to providing education, resources, and practical solutions to healthcare providers to help ensure access for all patients navigating this challenging disease.”