CHMP issues positive opinion to broaded indication for Janssen's Zytiga
Janssen-Cilag International announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended broadening the existing marketing authorisation for ZYTIGA 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 can be used for the treatment of adult men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer. 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 vs placebos and ADT. 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. 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.