The product received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency at its last meeting. The positive opinion will now be reviewed by the European Commission, which approves products for use in the European Union.
Apalutamide is already approved for this indication in the United States.
The positive opinion for this indication is based on results from the pivotal SPARTAN phase 3 clinical study, which has been published in the New England Journal of Medicine.
In this trial, the patients' prostate-specific antigen (PSA) levels had been rising rapidly despite continuous androgen deprivation therapy (ADT). The results showed that apalutamide, when added to ADT, significantly reduced the risk of developing distant metastasis or death; the risk for metastasis-free survival (MFS) was reduced by 72%, compared to placebo in combination with ADT (HR = 0.28; P < .001). The median MFS was improved by more than 2 years (40.5 months vs 16.2 months).
Apalumtamide was the first drug to be approved for use in the earlier stage of prostate cancer. It has since been joined by enzalutamide (Xtandi, Astellas/Pfizer), which was approved for nmCRPC in July 2018, having already been on the market for use in the later stages of the disease (metastatic CRPC).
The two drugs are now considered to be a new standard of care for this patient population with nmCRPC, who represent an unmet medical need. Previously, these patients were typically managed with surveillance.
These drug trials "are addressing a great clinical need for these patients, who currently generally only receive observation," Alexander Kutikov, MD, chief of urologic oncology at Fox Chase Cancer Center in Philadelphia, Pennsylvania, commented to Medscape Medical News earlier this year.
"The reported results will undoubtedly disrupt the treatment paradigms for these patients, delay the time to metastatic disease, and, ultimately, hopefully prove to extend survival," he said.
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Cite this: EU Green Lights Apalutamide for Nonmetastatic CRPC - Medscape - Nov 16, 2018.