"apalutamide (ARN-509) - Prostate cancer pre-metastatic castration-resistant" - Phase III
20171221 - U.S. FDA Grants Priority Review to Janssen for Apalutamide as a Treatment for Non-Metastatic Castration-Resistant Prostate Cancer
Apalutamide is an investigational, next-generation oral androgen receptor inhibitor that inhibits the action of androgen in prostate cancer cells, and prevents binding of androgen to the androgen receptor, and translocation of the androgen receptor to the nucleus of the cancer cell.
20180118 - with Pfizer in hot pursuit, JNJ loses a critical patent fight as it scrambles for a new prostate cancer drug OK
If J&J loses this battle, it still has a late-stage drug in front of the FDA — apalutamide, or ARN-509 — it’s hoping can protect the big revenue stream it gets from Zytiga (abiraterone), an oral drug that has helped revolutionize prostate cancer treatment over the last 5 years.
J&J won a priority review of apalutamide for nonmetastatic castration resistant prostate cancer, an early designation. And it’s fielding Phase III data that is slated to be revealed at the ASCO Genitourinary Cancers Symposium on February 8. The accelerated PDUFA date is in April.