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...
Relugolix (OrgovyxTM, Myovant Sciences) was recently FDA approved as the first oral hormone therapy for patients with advanced prostate cancer. In this interview, Neal Shore, MD, FACS, Medical Director of the Carolina Urologic Research Center and lead investigator of the HERO trial, on which the approval was based, speaks with i3 Health about the approval's significance and the future of treatment for patients with this disease. Can you comment on the significance of the approval of relugolix fo...
According to a recent cohort study, the use of active surveillance for low-risk prostate cancer is impacted by geographic location, despite a lack of association with Black race, the area's density of specialty physician's, or socioeconomic factors. "Active surveillance is now recognized as the preferred management option for most low-risk prostate cancers to minimize risks of overtreatment," write the investigators, led by first author Samuel L. Washington III, MD, MAS, an Assistant Professor o...
Relugolix (OrgovyxTM, Myovant Sciences) has been FDA approved for the treatment of patients with advanced prostate cancer. A gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix is the first oral hormone therapy to be approved for this disease. The approval was based on the phase 3 HERO trial (NCT03085095). "Relugolix was developed as an oral, highly selective, GnRH antagonist that is given once daily with an effective half-life of 25 hours," write the investigators in their June...
The FDA recently approved gallium (Ga) 68 PSMA-11, a radioactive diagnostic agent, for prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) imaging of patients with recurrent prostate cancer. Ga 68 PSMA-11, the approval of which was granted to the University of California San Francisco (UCSF) and the University of California Los Angeles (UCLA), is the first agent to be approved specifically for the detection of PSMA-positive lesions. In this interview with i3 Hea...