Zytiga: CHMP recommends to broaden indication to include the treatment of men with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer
The EMA’s 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 ).
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 ( ASCO ) Congress in Chicago, USA, and published in the New England Journal of Medicine ( NEJM ).
Abiraterone acetate plus Prednisone / Prednisolone has already been approved by the European Commission 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 phase 3, multinational, multicentre, randomised, double-blind, placebo-controlled LATITUDE study enrolled 1,199 newly diagnosed patients with metastatic hormone-naïve prostate cancer and was conducted at 235 sites in 34 countries in Europe, Asia-Pacific, Latin America, and Canada.
A total number of 597 patients were randomised to receive ADT in combination with Abiraterone acetate plus Prednisone ( n=597 ), while 602 patients were randomised to receive ADT and placebos ( n=602 ).
Patients included had high-risk mHNPC documented by positive bone scan or metastatic lesions at the time of diagnosis on computed tomography ( CT ) or magnetic resonance imaging ( MRI ).
Additionally, patients had to have at least two of the three following high-risk factors associated with poor prognosis: Gleason score greater than or equal to 8, greater than or equal to 3 bone lesions, presence of measurable visceral metastases. ( Xagena )
Source: Janssen, 2017