Priority Review of New Drug Application Granted to Apalutamide for CRPC
Patients in SPARTAN were randomly assigned to receive either apalutamide or placebo.
The US Food and Drug Administration (FDA) granted Priority Review to a New Drug Application for apalutamide, an androgen receptor inhibitor, for patients with castration-resistant prostate cancer (CRPC) without metastases, according to a press release.1
Data from the phase 3 SPARTAN trial (ClinicalTrials.gov Identifier: NCT01946204), which will be presented at the upcoming American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium in February 2018, led to the FDA's Priority Review designation for apalutamide.
In SPARTAN, patients with CRPC and a rapidly rising prostate-specific antigen (PSA), which continued to rise despite receipt of androgen-deprivation therapy, were randomly assigned to receive apalutamide or placebo. Patients with CRPC and rising PSA are at a particularly high risk of metastatic disease.
The FDA will take action on the New Drug Application within 6 months. Priority Review is granted only to drugs likely to drastically improve outcomes among patients with limited therapeutic options.
Apalutamide is a next-generation, orally administered inhibitor of the androgen receptor. Preclinical studies suggest that apalutamide prevents androgen binding to the androgen receptor.
Cancer Therapy Advisor will report on the data from SPARTAN, which will be presented at the ASCO Genitourinary Cancers Symposium on February 8, 2018.
1. U.S. FDA grants Priority Review to Janssen for apalutamide as a treatment for non-metastatic castration-resistant prostate cancer [news release]. Horsham, PA: Janssen Biotech, Inc; December 21, 2017. https://www.prnewswire.com/news-releases/us-fda-grants-priority-review-to-janssen-for-apalutamide-as-a-treatment-for-non-metastatic-castration-resistant-prostate-cancer-300574400.html. Accessed December 21, 2017.