Johnson & Johnson — Zytiga EMA EPAR variation assessment report (EMEA/H/C/002321, 2011)
Johnson & Johnson · 2011 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes a Type II variation application for Zytiga (abiraterone acetate) to expand its indication for newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC) in adult men, combined with androgen deprivation therapy (ADT). The application, submitted by Janssen-Cilag International NV to the EMA, is supported by the pivotal LATITUDE study. This trial (Study 212082PCR3011) demonstrated significant efficacy for abiraterone acetate plus prednisone (AA-P) with ADT versus ADT alone in high-risk mHNPC patients. AA-P significantly improved radiographic progression-free survival (rPFS) and overall survival (OS), reducing the risk of radiographic progression or death by 53% and the risk of death by 38%. The treatment also delayed the need for subsequent chemotherapy and other prostate cancer therapies.
Key findings — cited to the page
| median time to initiation of chemotherapy (Placebo) | 38.9 months | · p.36 |
| p-value for HR for radiographic progression or death | <0.0001 | · p.33 |
| subjects initiating chemotherapy (Placebo) | 31.7 % | · p.36 |
| p-value for HR for initiation of chemotherapy | <0.0001 | · p.36 |
| HR for radiographic progression or death | 0.466 | · p.33 |
| 95% CI for HR for radiographic progression or death | 0.394, 0.550 | · p.33 |
| number of subjects randomized | 1209 subjects | Europe, Asia, Australia, New Zealand, South Africa, Canada, Latin America · p.22 |
| ITT population | 1199 subjects | · p.22 |
| HR for initiation of chemotherapy | 0.443 | · p.36 |
| 95% CI for HR for initiation of chemotherapy | 0.349, 0.561 | · p.36 |
| randomization ratio | 1:1 | · p.18 |
| median rPFS | 33.0 months | · p.33 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →