J&J wins EU approval for Erleada in prostate cancer

17 January 2019

Janssen, the pharmaceuticals arm of US healthcare giant Johnson & Johnson (NYSE: JNJ), has won European approval for Erleada (apalutamide) for non-metastatic castration-resistant prostate cancer (nmCRPC).

The next generation oral androgen receptor inhibitor is approved for the treatment of adults who are at high risk of metastatic disease.

The EC approval is based on data from the pivotal Phase III SPARTAN study, which found that treatment with Erleada plus androgen deprivation therapy (ADT) reduced the risk of metastasis free survival (MFS) by 72%, compared to placebo plus ADT.

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