Janssen’s prostate cancer drug Zytiga (abiraterone) can now be used in Europe before chemotherapy after the European Commission approved the extension of its licence.
It can now be used, in combination with prednisone or prednisolone, to treat metastatic castration-resistant prostate cancer (mCRPC) in men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
Jane Griffiths, company group chairman, Janssen Europe, Middle-East, Africa, said: “Treating men with Zytiga before they undergo chemotherapy has been shown to improve outcomes in many patients, both in terms of extending survival and in bettering quality of life.
“The fact that Zytiga’s licence has now been extended to include this indication will help fill a critical medical need and, we hope, serve to significantly improve the lives of many men across Europe suffering from this disease.”
The once-daily oral drug, which was first approved in Europe in 2011, was previously only licensed to treat men suffering from mCRPC once their disease had progressed on, or after, a docetaxel-based chemotherapy regimen.
The European Commission’s decision follows Zytiga’s recommendation by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in November.
This was based on Janssen’s COU-AA-302 study, a phase III trial that involved over 1,000 patients and compared Zytiga plus prednisone/prednisolone to placebo plus prednisone/prednisolone.
The study’s co-primary endpoints were radiographic progression-free survival (rPFS), in which it showed a statistically significant improvement, and overall survival (OS).
Janssen said treatment with Zytiga showed a longer OS than with placebo in the trial, but that at the time of the interim analysis statistical significance for OS was not reached.
Nevertheless, in February 2012 an Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding the study and, based on its analysis, offering patients in the control arm treatment with Zytiga.
The approval should give Zytiga an advantage over Sanofi’s Jevtana (cabazitaxel), which is currently only indicated for second- and third-line use in mCRPC. It could also help cement Zytiga’s position over newer rivals, such as Astellas’ enzalutamide, which was approved in the US as Xtandi in September and was filed for European approval in June.