Date: 2011-12-20
Type of information: Granting of a Market Authorisation in the EU
Product name: Zytiga®
Compound: abiraterone acetate
Therapeutic area: Cancer - Oncology
Action mechanism:
- androgen synthesis inhibitor. Zitiga® inhibits production of androgen, which fuels prostate cancer growth, via inhibiting the CYP17 enzyme complex present at three sources: the testes, adrenals and the tumour itself.
Company: J&J (USA)
Disease:
- • treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
• treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
Latest news:
- • On January 11, 2013, Janssen-Cilag International has announced that the European Commission has approved an extension to the license of Zytiga® (abiraterone acetate). The approved broader indication for Zytiga® now includes its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.
Until now, Zytiga®with prednisone and prednisolone has only been approved to treat men with mCRPC whose disease has progressed on or after a docetaxel-based chemotherapy regimen. For information, the full indication for Zytiga® will be as follows:
• the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
• the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
The EC's decision follows recommendations from the CHMP of the European Medicines Agency that were based on data from the Phase III COU-AA-302 study.3 This was the first randomised study to demonstrate a radiographic progression-free survival (rPFS) benefit and a strong trend in overall survival (OS) in this patient population. Study COU-AA-302 is a Phase III, international, randomised, double-blind, placebo controlled study which evaluated Zytiga® plus prednisone/prednisolone compared to placebo plus prednisone/prednisolone in 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received prior chemotherapy. The co-primary endpoints of the study were radiographic progression-free survival (rPFS) and overall survival (OS). The results were published in The New England Journal of Medicine in December 2012 (Ryan C.J et al. Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy. N Engl J Med 2012) . The data demonstrated a statistically significant improvement in rPFS in the abiraterone acetate plus prednisone/prednisolone arm (Zytiga® arm) of the study compared to the placebo plus prednisone/prednisolone (control) arm. Additionally, treatment with Zytiga® plus prednisone/prednisolone resulted in a longer OS than with placebo (median OS in the Zytiga® arm was not reached because progression events occurred more slowly in the Zytiga® arm compared to the control arm. At the time of the interim analysis, statistical significance for OS was not reached. In February 2012 an Independent Data Monitoring Committee (IDMC) unanimously recommended unblinding of this study after the pre-specified analysis. Based on the results, the IDMC also recommended that patients in the control arm be offered treatment with Zytiga®.
- • On December 10, 2012, the FDA has approved a broader indication for the oral, once-daily medication Zytiga® (abiraterone acetate). Until now, Zytiga® with prednisone has only been approved to treat men with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel. With this approval, Zytiga® , in combination with prednisone, may now be used earlier in the treatment continuum for metastatic castration-resistant disease, before the use of chemotherapy.
- • On 15 November 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for Zytiga®. The CHMP adopted a new indication as follows: "Zytiga® is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated". The CHMP adopted a new contraindication as follows: "Severe hepatic impairment (Child-Pugh Class C)".
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-04-28 and 2012-12-10
UE authorization: 2011-09-05 and 2013-01-11
Favourable opinion UE: 2011-07-22 and 2012-11-15
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
