Janssen Biotech Inc. said FDA has granted priority review designation for the New Drug Application for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for the treatment of men with non-metastatic castration-resistant prostate cancer. Currently, there are no FDA-approved treatments for patients with non-metastatic CRPC.
The Priority Review designation means FDA’s goal is to take action on an application within six months of receipt, compared to 10 months for Standard Review. The FDA has assigned a Prescription Drug User Fee Act target date of April 2018 to render a decision on the apalutamide application.
The NDA submission for apalutamide, which was completed on Oct. 10, 2017, was based on phase III data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo in men with non-metastatic CRPC who have a rapidly rising prostate specific antigen despite receiving continuous androgen deprivation therapy.
The primary endpoint of this study was metastasis-free survival. MFS is the time from randomization to first evidence of confirmed metastasis, or time to death. The SPARTAN study results have been accepted for oral presentation at the ASCO Genitourinary Cancers Symposium Feb. 8, 2018, in San Francisco.
Apalutamide is an investigational, next-generation oral androgn 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.
