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Treatment Approval Broadened to Include Earlier Stage Prostate Cancer Patients

Disclosure: The European Medical Journal has engaged in business transactions with Janssen.

AN UNMET need in prostate cancer patients could be filled following the extension of European Commission (EC) marketing authorisation of the combination treatment abiraterone acetate (ZYTIGA®, Janssen, Beerse, Belgium) plus prednisone/prednisolone to include an earlier stage of metastatic prostate cancer. The treatment can now be used in combination with androgen deprivation therapy (ADT) in adult men newly diagnosed with high-risk metastatic hormone-sensitive prostate cancer.

Abiraterone acetate in combination with prednisone/prednisolone is the only treatment approved for metastatic castration-resistant prostate cancer (mCRPC) that inhibits production of androgens at the three sources crucial in prostate cancer: the testes, adrenals, and the tumour itself. Until now, the combination could only be used in adult men with mCRPC whose disease has progressed on or following a docetaxel-based chemotherapy regimen, or for those who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated.

The decision of the EC followed positive results from the LATITUDE trial, which led to a recommendation from the Committee for Medical Products for Human Use (CHMP). This trial enrolled 1,199 patients and compared the efficacy of ADT in combination with abiraterone acetate and prednisone with ADT alone. The Phase III, multinational, multicentre, randomised, double-blind, placebo-controlled study showed that, in newly diagnosed metastatic prostate cancer patients with high-risk prognostic factors who were naïve to castration, the safety profile of ADT in combination with abiraterone acetate and prednisone was consistent with earlier studies in mCRPC patients. The most commonly occurring adverse events were mineralocorticoid-related hypertension and hypokalaemia. However, only two patients had to discontinue treatment as a result of hypokalaemia and it was typically possible to manage any mineralocorticoid-related adverse events.

“Prostate cancer is the most common form of cancer in men throughout Europe and today’s decision helps to fill a critical medical need for these patients. We hope to significantly improve the lives of many men across Europe living with this disease and the approval of this treatment in an earlier stage of prostate cancer helps address this,” commented Prof Karim Fizazi, the principal investigator of the LATITUDE trial and Head of the Medical Oncology Department, Institute Gustave Roussy, Villejuif, France.

James Coker, Senior Editorial Assistant