First Therapy for Non-metastatic, Castration-resistant Prostate Cancer Patients Approved in US

First Therapy for Non-metastatic, Castration-resistant Prostate Cancer Patients Approved in US
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 metas
Subscribe or to access all post and page content.

One comment

Leave a Comment

Your email address will not be published. Required fields are marked *