Johnson & Johnson said the European Commission granted marketing authorization to its drug Erleada to treat certain adults with prostate cancer.
The EU regulator approved Erleada, or apalutamide, for treating adult patients with castration-resistant prostate cancer that has not spread and who are at high risk of developing metastatic disease — or the disease spreading across the body. The approval was granted to New Brunswick, N.J.-based Johnson & Johnson's Janssen Pharmaceutical Cos. subsidiary.
The decision is based on data from a phase 3 study called Spartan which evaluated Erleada combined with androgen deprivation therapy, or ADT, against placebo and ADT in prostate cancer patients.
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended Erleada's approval in November 2018. Erleada was also approved by the U.S. Food and Drug Administration in February 2018.