FDA Approves Erleada to Treat Metastatic Castration-sensitive Prostate Cancer

FDA Approves Erleada to Treat Metastatic Castration-sensitive Prostate Cancer
The U.S. Food and Drug Administration (FDA) has approved Erleada (apalutamide) for the treatment of men with metastatic castration-sensitive prostate cancer (mCSPC), or those whose cancer still responds to androgen deprivation therapy (ADT). The decision is based on the double-blind TITAN Phase 3 trial (NCT02489318), as it showed that adding Janssen’s Erleada to ADT significantly extended both overall survival and progression-free survival (PFS) – the period without cancer progression –, which were the trial’s primary goals. Compared to ADT and a placebo, treatment with Erleada and ADT reduced the risk of death by 33%, and the likelihood of disease worsening (as assessed by radiography) or death by 52%. After a median follow-up of 22.7 months, 84% of the patients on Erleada and ADT reached the two-year mark alive, compared to 78% of those on ADT and placebo. TITAN included 1,052 mCSPC patients regardless of extent of disease and of being newly diagnosed or having been treated with up to six cycles of docetaxel. It was funded by Johnson & Johnson-owned Aragon Pharmaceuticals and Janssen Research and Development (also owned by Johnson & Johnson). The frequency of serious adverse events was 19.8% for Erleada and 20.3% for placebo. A total of 42 and 28 patients (8% and 5.3%) discontinued treatment because of adverse events. Also, adverse events leading to death occurred in 10 (1.9%) patients on Erleada and in 16 (3.0%) on placebo. The study’s findings were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. Erleada is an oral therapy that targets the androgen receptor, blocking its activation by androgens such as testosterone. In turn, ADT, a mainsta
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