Leonard G. Gomella, MD
Now that the FDA has carved out nonmetastatic, castration-resistant prostate cancer (nmCRPC) as a new disease state, the decision about whether to administer recently approved antiandrogen therapies in this setting hinges on the rate of increase in prostate-specific antigen (PSA) levels and comorbidities, according to experts in the field.
The development of therapies for nmCRPC has been hailed as an advance for men with localized prostate cancer whose PSA levels continue to rise despite androgen deprivation therapy (ADT) and other treatment.
In February 2018, apalutamide (Erleada) became the first FDA-approved drug for nmCRPC, an indication that also marked the first time metastasis-free survival (MFS) was used as a primary endpoint in a clinical trial.1
Five months later, the agency broadened the indication for enzalutamide (Xtandi) to include patients with nmCRPC.2
(For both drugs, patients should also receive a gonadotropin-releasing hormone analogue concurrently or should have had bilateral orchiectomy). And in February 2019, a new drug application was submitted to the FDA for darolutamide, a novel androgen receptor agonist, in combination with ADT for patients with nmCRPC.3
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