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Erleada Approved for More Prostate Cancer Patients
The FDA has approved apalutamide (Erleada, Janssen) for the treatment of men with metastatic castration-sensitive prostate cancer.
The approval is based on the phase 3, randomized, placebo-controlled, double-blind TITAN study among 1,052 men who were chosen regardless of the extent of their disease or their prior docetaxel treatment.
Apalutamide plus androgen deprivation therapy (ADT) significantly extended overall survival (OS) compared to placebo plus ADT, with a 33% reduction in the risk of death. Apalutamide plus ADT also significantly improved radiographic progression-free survival compared to placebo plus ADT, with a 52% lower risk of radiographic progression or death. The two-year OS rates were 84% for apalutamide plus ADT compared to 78% for placebo plus ADT.
The most common adverse reactions with apalutamide in trials were fatigue, arthralgia, rash, decreased appetite, fall, weight decreased, hypertension, hot flush, diarrhea, and fracture.
About 40,000 men in the U.S. are diagnosed with metastatic castration-sensitive prostate cancer each year. Apalutamide, an androgen receptor inhibitor that is taken orally once a day, received FDA approval for non-metastatic castration-resistant prostate cancer in February 2018.
This application received a priority review designation and evaluation under the FDA Real-Time Oncology Review program.
Source: Janssen, September 17, 2019