The US Food and Drugs Administration has approved Apalutamide (Erleada) for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC). The drug is now the first FDA-approved treatment in this setting.
Non-Metastatic Castrate-Resistant Prostate Cancer is where men on Androgen Deprivation Treatment experience a rising PSA but where scans do not reveal the location of a new tumour. This new drug appears to delay the actual onset of metastases or spread for about 2 years.
The approval is based on the phase III SPARTAN trial in which apalutamide reduced the risk of metastasis or death by 72% in patients with non-metastatic CRPC. The median metastasis-free survival (MFS) was 40.5 months in the apalutamide arm versus 16.2 months in the placebo arm.
“The FDA evaluates a variety of methods that measure a drug’s effect, called endpoints, in the approval of oncology drugs. This approval is the first to use the endpoint of metastasis-free survival, measuring the length of time that tumors did not spread to other parts of the body or that death occurred after starting treatment,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public.”
The company, Janssen, which obtained the FDA approval has also made an application to the European Medicines Agency for marketing authorisation for the same drug.
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Richard Pazdur, MD