EMA Committee Favors Extending Use of Erleada for Metastatic Castration-sensitive Prostate Cancer

EMA Committee Favors Extending Use of Erleada for Metastatic Castration-sensitive Prostate Cancer
The Committee for Medicinal Products for Human Use recommends extending the use of Janssen’s Erleada (apalutamide), in combination with androgen deprivation therapy (ADT), to treat men with metastatic hormone-sensitive prostate cancer (mHSPC). CHMP’s positive opinion will now be reviewed by the European Commission, which will have the final word on expanding Erleada's indication in the European Union. mHSPC, also known as metastatic castration-sensitive prostate cancer (mCSPC), refers to prostate cancer that has spread to other parts of the body but still responds to ADT, or hormone therapy. Men with this type of prostate cancer tend to have poor outcomes, with a median overall survival of less than five years. Erleada is an inhibitor of the androgen receptor, blocking its activation by androgens such as testosterone. While also a hormone therapy, it works through a different mechanism than ADT, which reduces the level of androgens in the body, suggesting their combination could be better at extending survival outcomes. The recommendation by CHMP, an arm of the European Medicines Agency, was based on the TITAN Phase 3 trial (NCT02489318) which showed that Erleada added to ADT — the standard of care for men with mHSPC — prolonged overall survival and the time patients lived without disease worsening, compared to ADT only. The benefits were seen regardless of tumor volume, prior treatment with docetaxel, or cancer stage at diagnosis. TITAN, which was funded by Johnson & Johnson's Aragon Pharmaceuticals and Janssen, included 1,052 mCSPC patients with a broad range of clinical features: those with low- and high-volume disease, those who were newly diagnosed, and those who had received prior treatment for localized or metastatic disease. The
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