Specialty Drug Approvals
New Drug Approved for Prostate Cancer: Erleada® (apalutamide)
In February 2018, the U.S. Food and Drug Administration (FDA) approved Erleada® (apalutamide) for the treatment of patients with prostate cancer that has not spread to other areas (non-metastatic) and does not respond to other therapies used to lower testosterone (castration-resistant). Approval marks the first FDA-approved therapy for patients with this specific form of prostate cancer: non-metastatic, castration-resistant prostate cancer (NM-CRPC). Apalutamide is considered a next-generation androgen receptor (AR) inhibitor and in animal models has demonstrated a reduction in tumor volume through decreasing tumor cell growth and increasing cell death. The majority of patients with CRPC over time experience spread of the prostate cancer to the bone which can result in pain, fractures, and other complications. Therefore, delaying the onset of cancer spread in these patients is of considerable importance.