Janssen’s Zytiga approved in Europe for earlier-stage prostate cancer

Janssen has announced that its prostate cancer drug Zytiga has been approved for use in Europe among patients with earlier forms of the disease.

The European Commission has granted approval to broaden the existing marketing authorisation for Zytiga plus prednisone/prednisolone to include newly-diagnosed high-risk metastatic hormone-sensitive prostate cancer in adult men, in combination with androgen deprivation therapy (ADT).

This decision was based on positive data from the phase III LATITUDE trial, which offered evidence that newly-diagnosed patients with metastatic prostate cancer who are naive to castration and have high-risk prognostic factors would benefit from the addition of this therapy.

Dr Ivo Winiger-Candolfi, oncology solid tumour therapy area lead for Janssen in Europe, said: "This European Commission approval is a major step forward for men living with prostate cancer across Europe, and offers patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer a new treatment option."

The drug has already been approved for the treatment of metastatic castration-resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after the failure of ADT, for whom chemotherapy is not indicated, and for those who have failed to respond to docetaxel?based chemotherapy.

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