he European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended extending the use of the prostate cancer pill abiraterone acetate ( Zytiga, Janssen) to include men with advanced prostate cancer who fail on androgen-deprivation therapy.
The drug is currently approved in Europe and the United States for these same men, but only as second-line treatment, after docetaxel chemotherapy. If approved, abiraterone could be used by European clinicians as a first-line treatment for men who progress on androgen-deprivation therapy.
Specifically, CHMP recommended that abiraterone be administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after the failure of androgen-deprivation therapy.
A supplemental New Drug Application for this use was submitted to the US Food and Drug Administration (FDA) in June.
In both cases, the proposed expanded use of abiraterone is based on efficacy and safety results from an international phase 3 trial, which were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in June. The trial compared abiraterone plus prednisone with placebo plus prednisone in 1088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy. It has been criticized for being stopped too early and for the unproven nature of one of its primary end points.
However, European reviewers apparently agree with a study investigator who, at the ASCO meeting, said that the abiraterone data "merit consideration" as a "new standard approach" for the first-line treatment of mCRPC.
Abiraterone in combination with prednisone was approved by the FDA in April 2011 for the treatment of patients with mCRPC who have received previous chemotherapy containing docetaxel.
The drug reportedly costs $5000 per month in the United States.
The drug is currently approved in Europe and the United States for these same men, but only as second-line treatment, after docetaxel chemotherapy. If approved, abiraterone could be used by European clinicians as a first-line treatment for men who progress on androgen-deprivation therapy.
Specifically, CHMP recommended that abiraterone be administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after the failure of androgen-deprivation therapy.
A supplemental New Drug Application for this use was submitted to the US Food and Drug Administration (FDA) in June.
In both cases, the proposed expanded use of abiraterone is based on efficacy and safety results from an international phase 3 trial, which were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in June. The trial compared abiraterone plus prednisone with placebo plus prednisone in 1088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy. It has been criticized for being stopped too early and for the unproven nature of one of its primary end points.
However, European reviewers apparently agree with a study investigator who, at the ASCO meeting, said that the abiraterone data "merit consideration" as a "new standard approach" for the first-line treatment of mCRPC.
Abiraterone in combination with prednisone was approved by the FDA in April 2011 for the treatment of patients with mCRPC who have received previous chemotherapy containing docetaxel.
The drug reportedly costs $5000 per month in the United States.
