Johnson & Johnson filed an application with the U.S. Food and Drug Administration, seeking approval for apalutamide to treat a certain form of prostate cancer.
Apalutamide is an investigational oral androgen receptor inhibitor for treating men with non-metastatic castration-resistant prostate cancer. There are no FDA-approved treatments for the condition.
The submission is based on phase 3 data from the SPARTAN study, the results of which will be presented in a future medical meeting. Peter Lebowitz, Janssen's global therapeutic area head of oncology, said: "We have demonstrated that treating patients before the disease has metastasized improves outcomes."
Other than skin cancer, prostate cancer is the most common cancer among U.S. men. More than 161,000 men are estimated to be diagnosed with prostate cancer in 2017, according to the American Cancer Society.