Janssen-Cilag International NV has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended broadening the existing marketing authorisation for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of prostate cancer than its current indications. If approved by the European Commission, abiraterone acetate plus prednisone/prednisolone in combination with androgen deprivation therapy (ADT) can be used for the treatment of adult men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC).

“As shown by the results from the LATITUDE study, adding abiraterone acetate plus prednisone/prednisolone to ADT alone significantly improves overall survival and radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer and high-risk features in comparison to treating patients with ADT alone, where median survival is currently less than three years. The decision means we are one step forward in ensuring mHSPC men across Europe may be able to benefit from this treatment soon,” said Professor Karim Fizazi, principal investigator of the LATITUDE trial and Head of the Medical Oncology Department at Institute Gustave Roussy.

The CHMP recommendation is based on data from the multinational, multicentre, randomised, double-blind, placebo-controlled phase 3 study, LATITUDE. The trial was designed to determine if newly diagnosed patients with mHNPC who have high-risk prognostic factors benefit from the addition of abiraterone acetate and prednisone to androgen deprivation therapy (ADT) vs placebos and ADT. Data were presented at the 2017 American Society of Clinical Oncology congress in Chicago, USA and published in the New England Journal of Medicine.

“We are very pleased with the CHMP’s decision which recommends abiraterone acetate plus prednisone/prednisolone in combination with ADT for use in adult patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer. Janssen Oncology has played a significant role in transforming the way prostate cancer is treated so far and aims to continue this progress,” said Dr. Ivo Winiger-Candolfi, Oncology Solid Tumor Therapy Area Lead, Janssen Europe, Middle East and Africa.

Abiraterone acetate plus prednisone/prednisolone has already been approved by the European Commission (EC) for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated and of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. In the LATITUDE study, the safety profile of ADT in combination with abiraterone acetate plus prednisone was consistent with prior studies in patients with metastatic castration- resistant prostate cancer (mCRPC). Most common adverse events were elevated incidences of mineralocorticoid-related hypertension and hypokalemia in the ADT in combination with abiraterone acetate plus prednisone arm compared with ADT and placebos. The observed degrees of hypertension and hypokalemia were both medically manageable with antihypertensive medications and potassium supplements as needed, only rarely required treatment discontinuation, and seldom led to serious consequences.

The CHMP’s Positive Opinion will now be reviewed by the European Commission, which has the authority to grant approval of the new indication.