Life’s been tough for Johnson & Johnson’s prostate cancer med Erleada as it battles archrival Xtandi from Pfizer and Astellas. Lagging behind its competitor in the nonmetastatic form of the disease, Erleada can take solace in having a new indication to work with. The FDA on Tuesday approved Erleada as an add-on to androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer—which covers around 40,000 new patients in the U.S. each year, J&J said in a release. Erleada’s green light follows the FDA’s real-time review of the drug’s phase 3 Titan trial data, which showed Erleada plus ADT cut the risk of death over placebo plus ADT by 33%. After nearly two years, 84% of patients on Erleada-ADT were still alive, compared with 78% of the placebo-ADT group.
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