Bayer Aktiengesellschaft — Nubeqa EMA EPAR variation assessment report (EMEA/H/C/004790, 2020)
Bayer Aktiengesellschaft · 2020 · EMA EPAR variation assessment report · company profile →
Report summary
Bayer AG's Type II variation for Nubeqa (darolutamide) seeks to expand its indication to metastatic hormone-sensitive prostate cancer (mHSPC) in combination with ADT, supported by the Phase 3 ARANOTE study. ARANOTE demonstrated significant radiological progression-free survival (rPFS) improvement with darolutamide plus ADT versus placebo plus ADT, though overall survival (OS) did not reach statistical significance in the primary analysis. The ARASENS study, however, showed significant OS and rPFS benefits when darolutamide was combined with ADT and docetaxel. Pooled safety data from ARANOTE and ARAMIS studies indicate common adverse events including rash, hypertension, and cardiac disorders, with liver function and QT prolongation also monitored. While rPFS benefit is clear, concerns exist regarding ARANOTE's suboptimal comparator arm (ADT alone) and the non-significant OS trend. An updated Environmental Risk Assessment is also included.
Key findings — cited to the page
| anemia (any grade, ARANOTE+ARAMIS pooled, placebo arm) | 33.9 % | ARANOTE+ARAMIS pooled · p.68 |
| platelet count decreased (Grade 4, darolutamide arm) | 0.5 % | ARANOTE · p.68 |
| anemia (any grade, placebo arm) | 43.0 % | ARANOTE · p.67 |
| anemia (any grade, ARANOTE+ARAMIS pooled, darolutamide arm) | 44.4 % | ARANOTE+ARAMIS pooled · p.68 |
| platelet count decreased (any grade, placebo arm) | 9.3 % | ARANOTE · p.68 |
| platelet count decreased (Grade 3, darolutamide arm) | 0.5 % | ARANOTE · p.68 |
| thrombocytopenia (any grade, placebo arm) | 1.4 % | ARANOTE · p.68 |
| anemia (any grade, darolutamide arm) | 50.5 % | ARANOTE · p.67 |
| anemia (Grade 3, darolutamide arm) | 3.2 % | ARANOTE · p.67 |
| anemia (Grade 3, placebo arm) | 3.7 % | ARANOTE · p.67 |
| platelet count decreased (any grade, darolutamide arm) | 15.4 % | ARANOTE · p.68 |
| thrombocytopenia (any grade, darolutamide arm) | 2.2 % | ARANOTE · p.68 |
Source: Bayer Aktiengesellschaft ↗ · 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 →