Roche Holding AG — Alecensa EMA EPAR variation assessment report (EMEA/H/C/004164, 2017)
Roche Holding AG · 2017 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the EMA's assessment of a Type II variation application for Alecensa (Alectinib) as an adjuvant treatment for ALK-positive NSCLC. The application, based on the ALINA Phase III study (BO40336), sought to extend the indication to include adjuvant use and requested a 1-year market protection extension. The study demonstrated a significant benefit in Disease-Free Survival (DFS) for alectinib compared to chemotherapy, leading to the crossing of pre-specified stopping boundaries. Non-clinical aspects, including toxicology and carcinogenicity, and clinical pharmacology were reviewed. The EMA recommended approval for Alecensa's adjuvant use, citing improved DFS and an acceptable safety profile. Post-authorization studies are required for updated DFS, OS, and 5-year survival data.
Key findings — cited to the page
| Grade 3 and 4 TEAEs (treatment arm) | 29.7 % | · p.77 |
| Grade 3 and 4 TEAEs (control arm) | 30.8 % | · p.77 |
| Type II variation application submission date | 24 November 2023 | Alecensa · p.6 |
| CHMP Opinion date | 25 April 2024 | · p.7 |
| ALK fusion prevalence in NSCLC | 4–5% | · p.8 |
| Brain metastases rate in ALK-positive NSCLC | ~50-60% | · p.8 |
| 5-year survival rate | 60-73% | · p.8 |
| Cancer recurrence rate within 5 years after initial diagnosis | 40-46% | · p.8 |
| Alectinib treatment duration in non-clinical studies | 2 years | · p.9 |
| Alectinib plasma exposure at NOEL (Cmax) | 1850 ng/mL | · p.10 |
| median DFS (chemotherapy arm, Stage II-IIIA) | 44.4 months | ALINA · p.37 |
| EMA Decision on paediatric waiver | P/0359/2018 | · p.6 |
Source: Roche Holding AG ↗ · 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 →