The U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s Erleada (apalutamide), a next-generation androgen receptor inhibitor, as therapy for patients with localized (non-metastatic) prostate cancer who failed to respond to hormone therapy.
This makes Erleada the first FDA-approved therapy for non-metastatic, castration-resistant prostate cancer.
The decision was supported by results from SPARTAN (NCT01946204), a Phase 3 trial showing that treatment with Erleada decreased the risk of cancer spreading (metastasis) or death by 72 percent, and increased the time it took for the cancer to metastasize by more than two years.
The study included 1,207 patients with non-metastatic, castration-resistant prostate cancer whose PSA levels were rapidly rising while receiving androgen deprivation therapy. Participants were randomly assigned oral Erleada, or placebo, once daily.
During the trial, all participants continued to receive hormone therapy or had a bilateral orchiectomy (surgery to remove both testicles).
The median time a patient went without developing metastasis was 40.5 months (three years and four months) among those who received Erleada. This represented a more than two-year increase in the 16.2 months seen in patients treated with placebo.
The benefit was seen across patient subgroups, including in patients with high rates of disease progression.
Erleada also led to statistically significant improvements in several other measures, including time to metastasis, time to disease progression or death, and time to symptomatic progression.
The trial results were recently published in The New England Journal of Medicine in a study titled, “Apalutamide Treatment and Metastasis-free Survival in Prostate Cancer.”
“The need to delay metastasis is critical to the treatment of prostate cancer. Nearly 90 percent of patients with castration-resistant prostate cancer will eventually develop bone metastases, at which point the prognosis sharply worsens,” Mathai Mammen, MD, PhD, global head of Johnson & Johnson subsidiary Janssen Research & Development, said in a press release.
“We are excited about what this approval means for patients living with prostate cancer, and that physicians now have an important and much-needed treatment option that has been shown to delay the progression of castration-resistant prostate cancer,” he said.
“As the impact of prostate cancer continues to grow, we are reminded every day of the critical need for therapeutic options that offer patients with prostate cancer more time with their loved ones,” said Mark Scholz, MD, executive director of the Prostate Cancer Research Institute. “Today’s approval is significant, as it means that patients with non-metastatic castration-resistant prostate cancer now have a treatment option that offers renewed hope.”