The recent first global approval of Apalutamide has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight.
In mid-February 2018, apalutamide (Erleada™), developed by Janssen, received its first global approval in the US for the treatment of non-metastatic, castration-resistant prostate cancer (NM-CRPC). Apalutamide is an orally administered next-generation androgen receptor inhibitor that has a triple action regarding the inhibition of cancer cell growth. It prevents:
- direct androgen binding to the androgen receptor
- the androgen receptor entering cancer cells
- the androgen receptor from binding to cancer cell DNA.
The American Cancer Society has predicted there will be almost 164,700 new cases of prostate cancer in the US, of which almost 18% will be fatal.
In 90% of cases metastatic disease will develop, involving bone in particular, and resulting in pain, fractures and spinal compression. In patients with non-metastatic castration-resistant prostate cancer it is imperative to stop the onset of metastasis for as long as possible.
“As an oncologist and clinical investigator, I know how devastating it can be for patients and their families to hear that the cancer has spread,” commented Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program at the Massachusetts General Hospital Cancer Center, Professor of Medicine at Harvard Medical School, and co-principal investigator of the SPARTAN study. He went on to explain that, “with this approval, doctors now have the chance to offer hope for delaying metastases in patients with castration-resistant prostate cancer.” 
The positive metastatic-free survival rates observed in the phase III SPARTAN study were used to support the approval of apalutamide in the US, which was given Priority Review designation. The agent is currently under regulatory review in the EU and Japan for the same indication. 
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