Dr. Tan Discusses the FDA Approval of Darolutamide in M0CRPC

Winston Tan, MD
Published: Wednesday, Jul 31, 2019



Winston Tan, MD, hematologist/oncologist, Mayo Clinic, discusses the FDA approval of darolutamide (Nubeqa) in nonmetastatic castration-resistant prostate cancer (M0CRPC).

The approval of the next-generation androgen receptor inhibitor is based on data from the phase III ARAMIS trial, in which the combination of darolutamide and androgen deprivation therapy (ADT) led to a 59% reduction in the risk of metastases or death compared with placebo/ADT in patients with M0CRPC (HR, 0.41; 95% CI, 0.34-0.50; 2-sided, P <.0001). At a median follow-up of 17.9 months, the median metastasis-free survival (MFS) was 40.4 months with the addition of darolutamide compared with 18.4 months with placebo/ADT.

Notably, the oral drug has a lower incidence of falls and fracture rates than other available drugs in this setting, says Tan. The drug may be especially valuable for elderly patients with comorbidities, he adds. Darolutamide also has the potential to be superior to other available agents in this setting in terms of tolerability and cost, says Tan.
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Winston Tan, MD, hematologist/oncologist, Mayo Clinic, discusses the FDA approval of darolutamide (Nubeqa) in nonmetastatic castration-resistant prostate cancer (M0CRPC).

The approval of the next-generation androgen receptor inhibitor is based on data from the phase III ARAMIS trial, in which the combination of darolutamide and androgen deprivation therapy (ADT) led to a 59% reduction in the risk of metastases or death compared with placebo/ADT in patients with M0CRPC (HR, 0.41; 95% CI, 0.34-0.50; 2-sided, P <.0001). At a median follow-up of 17.9 months, the median metastasis-free survival (MFS) was 40.4 months with the addition of darolutamide compared with 18.4 months with placebo/ADT.

Notably, the oral drug has a lower incidence of falls and fracture rates than other available drugs in this setting, says Tan. The drug may be especially valuable for elderly patients with comorbidities, he adds. Darolutamide also has the potential to be superior to other available agents in this setting in terms of tolerability and cost, says Tan.



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