16 Aug FDA Approves Nubeqa®(darolutamide) for Non Metastatic Castration-Resistant Prostate Cancer
MedicalResearch.com Interview with:
Neal D. Shore, MD, FACS
Director, CPI, Carolina Urologic Research Center
Atlantic Urology Clinics
Myrtle Beach, South Carolina
Neal D. Shore, MD, FACS is the Medical Director for the Carolina Urologic Research Center. He practices with Atlantic Urology Clinics in Myrtle Beach, South Carolina.
Dr. Shore discusses the recent announcement that the FDA has approved Nubeqa®(darolutamide), for the treatment of patients with non-metastatic castration-resistant prostate cancer..
MedicalResearch.com: What is the background for this study? How does NUBEQA®(darolutamide) differ from other treatments for nmCRPC?
Response: In 2017, patients did not have an approved therapy for non-metastatic castration-resistant prostate cancer, or nmCRPC. If untreated, patients with this diagnosis will go on to develop metastases, or progression of the cancer throughout the body. NUBEQA® (darolutamide) became the third and most recently approved treatment for nmCRPC, demonstrating a benefit of metastasis-free survival, or MFS.
NUBEQA is different due to its adverse event and safety profile reported in the Phase III ARAMIS trial. In that study, there were no significant findings of falls and fractures as well as other adverse events reported from the earlier Phase III trials.
MedicalResearch.com: What are the main findings of the NEJM article, “Darolutamide in Nonmetastatic, Castration-Resistant Prostate Cancer”?
Response: NUBEQA met its primary endpoint of metastasis-free survival. In further analyses, NUBEQA demonstrated a delay in prostate-specific antigen (PSA) progression and delay in onset for additional cancer therapies. The overall survival benefit for NUBEQA is still pending and results should be available in the near future.
MedicalResearch.com: What should readers take away from your report?
Response: Patients now the option to choose among three oral medications that have been approved for the treatment of nmCRPC. I’m impressed by the safety and adverse event profile of NUBEQA, which may be due to its unique molecular structure.
Disclosures: Dr. Shore does research and consulting for numerous companies in the genitourinary and oncology fields.
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