Men with non-metastatic castrate-resistant prostate cancer will soon know whether or not apalutamide is helpful. The USA based Food and Drug Administration has cut the review time from ten to six months.
We might hear the FDA’s ruling as early as April, 2018. Apalutamide (ARN-509) is an androgen receptor inhibitor and might prove to be one of the few ways that non-metastatic castrate-resistant men can be treated. It’s taken orally and helps prevent testosterone from binding to its receptor, blocking its pro-tumoral effects in prostate cancer cells.
The FDA is reviewing data from a Phase 3 clinical trial called, SPARTAN . SPARTAN investigated whether apalutamide was better than placebo at delaying the progression of non-metastatic CRPC into a more aggressive, metastatic form of cancer. 1,200 men participated in the trial.
Early data is promising, showing that men receiving ADT plus apalutamide lived significantly longer without cancer progression (measured by distant metastasis formation), than those receiving ADT plus a placebo.