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19528811000001106

Medicine Compliance Aid Stability

ZytigaJanssen-Cilag Ltd

Janssen-Cilag Ltd
Zytiga
Tablets 250mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Caution in handling by female operatives
Should not be handled by pregnant women and women of childbearing potential
18 September 2015

New Medicines

Zytiga Metastatic castration-resistant prostate cancer - first-line in combination with niraparib and prednisone

Information

Zytiga
Licence extension / variation
Janssen-Cilag
Janssen

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Phase III Clinical Trials
Apr 22Filed in the EU, supported by data from the PIII MAGNITUDE study [3].

Category

An androgen biosynthesis inhibitor. Abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues.
Prostate cancer is the most common cancer in men and makes up 26% of all male cancer diagnoses in the UK. The age-standardised incidence of prostate cancer in the UK in 2014 was 175 per 100,000 population [1].
Metastatic castration-resistant prostate cancer - first-line in combination with niraparib and prednisone
Oral

Trial or other data

Feb 22Data announced from PIII MAGNITUDE study. The cohort of patients with prospectively-identified HRR gene alterations enrolled 423 patients, with patients randomised to receive the combination of niraparib and abiraterone acetate plus prednisone (combination arm [n=212]) or placebo and abiraterone acetate plus prednisone (control arm [n=211]). At 18.6-month median follow-up, patients in the combination arm of the cohort with HRR gene alterations showed a significant improvement in rPFS, with a reduction in the risk of progression or death of 27 percent (hazard ratio [HR] 0.73; p=0.022). This improvement was most pronounced in patients with BRCA1/2 gene alterations, where a 47 percent risk reduction was observed for rPFS (HR 0.53; p=0.001), as analyzed by blinded independent central review (BICR). A consistent but greater improvement was observed in investigator-assessed rPFS, which showed an overall 36 percent risk reduction in patients with HRR gene alterations (HR: 0.64; p=0.002), and a 50 percent risk reduction in patients with BRCA1/2 gene alterations (HR: 0.50; p=0.0006). The cohort without HRR gene alterations (n=233) met the predefined futility criteria in August 2020, showing no benefit from the treatment combination (HR>1) in the HRR biomarker negative population. Additionally, objective response rate was improved by the combination of niraparib and abiraterone acetate plus prednisone. Overall survival data were immature at this interim analysis and follow-up will continue for all secondary endpoints [2,3].
Feb 19PIII MAGNITUDE trial to compare niraparib in combination with abiraterone acetate and prednisone vs. abiraterone and prednisone in patients with metastatic castration resistant prostate cancer starts (NCT03748641; 64091742PCR3001; CR108534). 1,000 patients will be recruited in countries including the US & EU (plus UK). Collection of primary outcome date (radiographic progression-free survival) is due to complete Jul 22 [2].

ZytigaMetastatic hormone sensitive prostate cancer - with niraparib

Information

Zytiga
Licence extension / variation
Janssen-Cilag
Janssen

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

An androgen biosynthesis inhibitor. Abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues.
Prostate cancer is the most common cancer in men and makes up 26% of all male cancer diagnoses in the UK. The age-standardised incidence of prostate cancer in the UK in 2014 was 175 per 100,000 population [1].
Metastatic hormone sensitive prostate cancer - with niraparib
Oral