HOFFMANN-LA ROCHE — Alecensa FDA Review (NDA/BLA 208434, 2024)
Roche Holding AG · 2024 · FDA Review (Drugs@FDA) · company profile →
Report summary
The FDA reviewed a supplemental New Drug Application for Alecensa (alectinib) as an adjuvant treatment for ALK-positive non-small cell lung cancer (NSCLC) following tumor resection. The ALINA trial demonstrated statistically significant and clinically meaningful improvement in disease-free survival (DFS) for alectinib compared to chemotherapy, with a median DFS not reached in the alectinib arm versus 41.3 months for chemotherapy. The proposed 600 mg BID dosing regimen was deemed appropriate. Safety profiles were consistent with previous studies, showing a generally well-tolerated profile with lower treatment discontinuation rates due to adverse events despite longer exposure. The review included detailed efficacy, safety, pharmacokinetic data, and financial disclosures, concluding with a recommendation for traditional approval.
Key findings — cited to the page
| patients with at least one Grade 3-5 AE | 29.7 % | ALINA study · p.80 |
| patients with at least one Grade 3-5 AE | 30.8 % | ALINA study · p.80 |
| Grade ≥3 AEs (hepatotoxicity) | 4.7 % | ALINA study · p.80 |
| Grade ≥3 AEs (fatigue, leukopenia, nausea) | 4.2 % | ALINA study · p.80 |
| patients with at least one Grade 3-5 selected AE | 27.5 % | ALINA study · p.78 |
| Grade ≥3 AEs | 30 % | ALINA study · p.80 |
| Grade ≥3 AEs | 31 % | ALINA study · p.80 |
| Grade ≥3 AEs (increased blood CPK) | 6 % | ALINA study · p.80 |
| Grade ≥3 AEs (pneumonia, appendicitis) | 3.1 % | ALINA study · p.80 |
| Grade ≥3 AEs (neutropenia) | 18 % | ALINA study · p.80 |
| patients with at least one Grade 3-5 selected AE | 17.2 % | ALINA study · p.78 |
| grade ≥3 CPK elevation incidence (overall pooled population) | 6 % | · p.17 |
Source: Roche Holding AG ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →