The FDA has approved apalutamide (Erleada, Janssen) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC), based on the results from the Phase 3 TITAN study. Apalutamide was approved for nonmetastatic castration-resistant prostate cancer in 2018.

The study showed that apalutamide combined with androgen deprivation therapy (ADT) reduced the risk of death by 33% compared to ADT combined with a placebo. This was the first registrational study to achieve statistical significance in dual primary endpoints of overall survival and radiographic progression-free survival in patients with mCSPC.

Participants in the trial were recruited regardless of the extent of their disease, including both high- and low-volume disease, or prior docetaxel treatment history. As reported in the The New England Journal of Medicine, the 2-year overall survival rates, after a median follow-up of 22.7 months, were 84% for apalutamide plus ADT, compared to 78% for the placebo plus ADT.

“Prostate cancer is more difficult to treat once it spreads, and for patients with castration-sensitive disease, it is clear that androgen deprivation therapy (ADT) alone is often not enough,” said Kim Chi, MD, medical oncologist at BC Cancer-Vancouver and principal investigator of the TITAN study, in a prepared statement.

The most common adverse reactions from the randomized placebo-controlled clinical trials were fatigue, arthralgia, rash, decreased appetite, falls, decreased weight, hypertension, hot flush, diarrhea, and fractures.


U.S. FDA Approves Supplemental New Drug Application (sNDA) for ERLEADA® (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC) [news release]. Horsham, PA; September 17, 2019: Janssen. Accessed September 18, 2019.