Janssen announces European Commission approval of ERLEADA® (apalutamide) for non-metastatic castration-resistant prostate cancer patients who are at high risk of developing metastatic disease

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the European Commission (EC) has granted marketing authorisation for ERLEADA® (apalutamide), an oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.[ii]

The EC approval is based on data from the pivotal Phase 3 SPARTAN study, which was published in The New England Journal of Medicine.The study assessed the efficacy and safety of apalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in patients with nmCRPC who had a rapidly rising prostate specific antigen (defined as a PSA doubling time of 10 months or less) despite receiving continuous ADT.Findings from the study showed that apalutamide plus ADT, significantly reduced the risk of developing distant metastasis or death (metastasis free survival [MFS]) by 72 percent, compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P < 0.001).The median MFS (metastatic free survival) was improved by over two years (40.5 months vs. 16.2 months) in patients with nmCRPC whose PSA is rapidly rising.1

Professor John McCaffrey, Consultant Medical Oncologist at the Mater Hospital in Dublin, Ireland, “One of the key goals for prostate cancer patients is to delay the onset of secondary or stage 4 disease when the disease spreads from the prostate into other organs such as the bones. Once this happens the cancer can be less responsive to treatment including hormonal therapy and chemotherapy. This negatively impacts on the patients’ quality of life, worsens symptoms and will shorten their lifespan.”

“The use of Apalutamide has brought a significant clinical benefit to patients and their families as it delays the onset of the spread of the cancer. This significantly alleviates the burden on the patient, both in terms of symptom alleviation and improved psychological benefit. This reduces the additional workload on staff and resources because Apalutamide can be delivered orally with minimal safety concerns,” said Professor John McCaffrey, Consultant Medical Oncologist at the Mater Hospital in Dublin, Ireland.


The approval of apalutamide is a significant milestone and we are pleased that we can now offer patients with high-risk non-metastatic castration-resistant prostate cancer a new treatment option,” said Laurent de Saint Sernin, General Manager Commercial Operations, Janssen Sciences Ireland UC, “Bringing medicines to patients at earlier stages of disease is vital, and the approval of apalutamide could mark a step change in how we treat prostate cancer in the future. Crucially, treating patients at this stage could delay the cancer from spreading, a key part of our commitment to patients living with this disease and to their families.”

The most common Grade 3/4 treatment-emergent adverse events in the SPARTAN study were hypertension (14.3 percent vs. 11.8 percent), rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent). Treatment discontinuation due to adverse events was 11 percent in the apalutamide arm compared to 7 percent in the placebo arm. Rates of serious adverse events were similar in the apalutamide in combination with ADT arm versus placebo in combination with ADT arm (25 percent vs. 23 percent respectively).1

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