The FDA grants Priority Review designation to investigational therapies that, if approved, may offer significant improvements in the safety and effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications.1 This designation means the FDA’s goal is to take action on an application within six months of receipt, compared to 10 months for Standard Review.1 The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of April 2018 to render a decision on the apalutamide application.
“The prognosis for men with prostate cancer is significantly worse once the cancer has spread to other parts of the body. Accordingly, men with non-metastatic castration-resistant prostate cancer need treatment options that can delay disease progression and improve long-term outcomes,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. “We are encouraged by the FDA’s recognition, via the priority review designation, of the potential for apalutamide to provide such an option for these men.”The NDA submission for apalutamide, which was completed on October 10, 2017, was based on Phase 3 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 (PSA) despite receiving continuous androgen deprivation therapy (ADT).2 These men with a rapidly rising PSA are at high risk for developing metastatic disease.3,4 The primary endpoint of this study was metastasis-free survival (MFS).2 MFS is the time from randomization to first evidence of confirmed metastasis, or time to death.5 The SPARTAN study results have been accepted for oral presentation at the ASCO Genitourinary Cancers Symposium on Thursday, February 8, 2018, in San Francisco.
1 Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf. Accessed in December 2017.
2 Clinical trials gov. A Study of Apalutamide (ARN-509) in Men with Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN). Available at: https://clinicaltrials.gov/ct2/show/NCT01946204. Accessed December 2017.
3 Smith MR, et al. Natural history of rising serum prostate-specific antigen in men with castrate nonmetastatic prostate cancer. J Clin Oncol. 2005;23:2918-2925.
4 Lin JH, et al. Association of prostate specific-antigen doubling time (PSADT) with metastasis-free survival (MFS) and overall survival (OS) in non-metastatic castration-resistant prostate cancer (nmCRPC). J Clin Oncol 2017;35(15 suppl). Abstract e16525.
5 Xie W, et al. Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer. Journal of Clinical Oncology. 2017; 0732-183X/17/3599-1.
New Drug Application Submitted to FDA for Apalutamide to Treat Men with Non-Metastatic Castration-Resistant Prostate Cancer
ASCO GU 2017: Phase Ib study of apalutamide (APA) with abiraterone acetate (AA) and prednisone (P) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
WATCH: Phase 2 Study of the Safety and Antitumor Activity of Apalutamide in the High-risk Nonmetastatic Castration-resistant Prostate Cancer - Charles Ryan
CLINICAL TRIAL: Active Surveillance With or Without a 6 Months Apalutamide Treatment in Low Risk Prostate Cancer: A Phase II Randomized Multicenter Trial