The FDA has added new overall survival and other secondary outcome data to the prescribing information for darolutamide (Nubeqa®, Bayer), an androgen receptor inhibitor which was approved for the treatment of nonmetastatic castration-resistant prostate cancer (CRPC) in 2019. The updates were based on the final analysis of the phase 3 ARAMIS trial (NCT02200614), led by first author Karim Fizazi, MD, Head of the Department of Cancer Medicine at the Institut Gustave Roussy in Villejuif, France. The...
In this interview, Nicholas Vogelzang, MD, speaks with i3 Health about the recent FDA approval of rucaparib (Rubraca®, Clovis Oncology, Inc.) for the treatment of patients with metastatic BRCA-mutated castration-resistant prostate cancer (CRPC) who previously received one line of taxane-based chemotherapy and at least one line of androgen receptor-directed therapy. Dr. Vogelzang, Clinical Professor of Medicine at the University of Nevada School of Medicine and one of the investigators of the TRI...
The FDA has approved olaparib (LynparzaTM, AstraZeneca Pharmaceuticals LP) for adult patients with homologous recombination repair (HRR)–mutated metastatic castration-resistant prostate cancer (CRPC) who experience disease progression after treatment with enzalutamide or abiraterone acetate. In addition, the FDA approved two companion diagnostic devices: FoundationOne® CDx (Foundation Medicine, Inc.), for the identification of HRR gene alterations, and BRACAnalysis CDx®(Myriad Genetics, Inc...
The FDA has granted accelerated approval to rucaparib (Rubraca®, Clovis Oncology, Inc.) for patients with deleterious germline and/or somatic BRCA-mutated metastatic castration-resistant prostate cancer (CRPC) who have previously received one line of taxane-based chemotherapy and one or more lines of androgen receptor-directed therapy. The approval was based on TRITON2 (NCT02952534), a phase 2 clinical trial which enrolled 115 patients with BRCA-mutated metastatic CRPC. Patients received 600 mg ...
In the past decade, much progress has been made in the management of castration-resistant prostate cancer (CRPC), with numerous new agents improving outcomes in patients with this disease. However, many challenges still remain. In this interview with i3 Health, Judd W. Moul, MD, FACS, Professor of Urologic Surgery at the Duke School of Medicine, discusses strategies that community oncologists and urologists can utilize to determine the best treatment for their patients. He also discusses the rol...