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 Editorial Director for That’s Nice and the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content. 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 and a Ph.D. in Genetics and Development from Columbia University.