Zytiga
Oncology· 2472 cited findings· 4 source documents
Company: Johnson & Johnson →
What the regulatory reviews say
Zytiga (abiraterone acetate) received regular approval on December 10, 2012, for the treatment of metastatic castration-resistant prostate cancer. This approval followed a PDUFA Goal Date of December 14, 2012. The NDA number for this approval was 202379/S005.
In a Phase 3 trial (Study 1, N=1195 patients), the median overall survival (OS) for the abiraterone arm was 35.3 months, compared to 30.1 months for the placebo arm, with a Hazard Ratio (HR) for OS of 0.79. The median radiographic progression-free survival (rPFS) was 8.3 months for the abiraterone arm, with a HR for rPFS of 0.43 (95% CI: 0.35, 0.52) and a p-value of < 0.0001. The median duration of treatment with Zytiga in Study 1 was 8 months.
Safety findings included Grade 3-4 hypertension in 2% of patients, Grade 3-4 hypokalemia in 2% of patients, and Grade 3-4 bilirubin elevation in 0.2% of patients. There were 26 reported cases of pulmonary embolism in the post-marketing adverse event reporting database, with 774 post-marketing reports submitted and a worldwide exposure of 2,245,830 person-days.
Key figures — cited to the source page
| Approval Date | 12/10/2012 | JANSSEN BIOTECH — Zytiga FDA Review, p.1 |
| Indication | treatment of metastatic castration-resistant prostate cancer | JANSSEN BIOTECH — Zytiga FDA Review, p.1 |
| Median OS (abiraterone acetate) | 35.3 months | JANSSEN BIOTECH — Zytiga FDA Review, p.42 |
| Median OS (placebo) | 30.1 months | JANSSEN BIOTECH — Zytiga FDA Review, p.42 |
| HR for OS | 0.79 | JANSSEN BIOTECH — Zytiga FDA Review, p.42 |
| HR for rPFS | 0.43 | JANSSEN BIOTECH — Zytiga FDA Review, p.42 |
| Grade 3 to 4 hypertension | 2 % | JANSSEN BIOTECH — Zytiga FDA Review, p.11 |
| Hypokalemia Grade 3-4 | 2 % | JANSSEN BIOTECH — Zytiga FDA Review, p.178 |
Source documents
- JANSSEN BIOTECH — Zytiga FDA Review (NDA/BLA 202379, 2018) (2018)
- JANSSEN BIOTECH — Zytiga FDA Review (NDA/BLA 202379, 2016) (2016)
- Johnson & Johnson — Zytiga EMA EPAR public assessment report (EMEA/H/C/002321, 2011) (2011)
- Johnson & Johnson — Zytiga EMA EPAR variation assessment report (EMEA/H/C/002321, 2011) (2011)
Explore the full evidence
All 2472 cited findings for Zytiga — searchable, comparable and answerable in plain language — are in the Oncology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.