The NCCN has listed apalutamide (Erleada) as a category 1 recommendation for the treatment of men with non-metastatic castration-resistant prostate cancer (M0 & CRPC).
In new treatment guidelines that were issued on March 8, 2018, the NCCN included Erleada as a category 1 treatment option for men with M0 disease, especially in those for whom PSA doubling time is ≤10 months. Men with a doubling time of ≤10 months are those who are most likely to develop metastases and death.
The FDA approved Erleada in February 2018. The approval was based on results from the international, placebo-controlled randomized, phase III SPARTAN trial in which apalutamide reduced the risk of metastasis or death by 72% in men with non-metastatic CRPC. The median metastasis-free survival (MFS) was 40.5 months in the apalutamide arm versus 16.2 months in the placebo arm (HR, 0.28; 95% CI, 0.23-0.35; P<.0001).
Patient-reported outcomes indicated that patients who received apalutamide in addition to androgen-deprivation therapy maintained stable overall health-related quality of life over time, as did patients in the placebo group.
The NCCN’s acceptance of Erleada as a category 1 treatment makes it most likely that insurance coverage for the treatment will be quickly extended to the drug.
Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and the rare cancer Appendiceal cancer.