FDA Will Use Real-Time Oncology Review for Prostate Cancer Drug

The agency will start reviewing data on J&J’s Erleada before the company submits its complete application.


Erleada (apalutamide) is an androgen receptor (AR) inhibitor developed by Johnson & Johnson. It is the first therapy approved (February 2018) by the U.S. Food and Drug Administration (FDA) to treat patients with non-metastatic castration-resistant prostate cancer, according to the company.


J&J has also been investigating Erleada as a treatment in combination with androgen deprivation therapy (ADT) for patients with metastatic, castration-sensitive prostate cancer (mCSPC). At the end of January 2019, the company halted a phase III study early because this treatment regimen significantly delayed disease progression and extended the lives of patients.


The FDA recently accepted J&J’s application to expand Erleada’s approval to include patients with metastatic, castration-sensitive prostate cancer and will evaluate the filing under the Real-Time Oncology Review program, which allows the agency to begin reviewing the data for J&J’s application when it is complete.


The approval is important for J&J because sales of its older prostate cancer drug Zytiga are declining in the face of generic competition.


The company faces branded competition for Erleada too, though. Pfizer and Astellas beat J&J to the market with their prostate cancer drug Xtandi (enzalutamide), a second-generation nonsteroidal antiandrogen (NSAA) medication, which the FDA approved for the treatment of metastatic castration-resistant prostate cancer and nonmetastatic castration-resistant prostate cancer. Xtandi is also in trials for the treatment of metastatic hormone-sensitive patients with and without ADT.


David Alvaro, Ph.D.

David is Scientific Editor in Chief of the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content, in addition to serving as Scientific Research Director for That's Nice. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University in 1999 and a Ph.D. in Genetics and Development from Columbia University in 2008.