HOFFMANN-LA ROCHE — Alecensa FDA Summary Review (NDA/BLA 208434, 2016)
Roche Holding AG · 2016 · FDA Summary Review (Drugs@FDA) · company profile →
Report summary
This FDA summary reviews Alectinib (Alecensa) for ALK-positive NSCLC, detailing its clinical pharmacology, efficacy, and safety. Pharmacokinetic data supports the proposed dosage. Efficacy, demonstrated in two single-arm trials (NP28761 and NP28673), showed favorable objective response rates and duration of response in patients whose disease progressed on crizotinib. While common and serious adverse reactions, including fatal events, hepatic toxicity, ILD, bradycardia, and myalgia, were identified, the overall benefit-risk profile was deemed favorable for approval, with post-marketing requirements outlined.
Key findings — cited to the page
| Grade 3 myalgia/musculoskeletal pain | 1.2 % | · p.21 |
| Grade 3 elevations in CPK levels | 4.6 % | · p.21 |
| Patients requiring at least one dose reduction for adverse reactions | 23 % | · p.21 |
| Elevated CPK levels leading to dose reductions/interruptions | 4.3 % | · p.21 |
| Elevated ALT levels leading to dose reductions/interruptions | 4.0 % | · p.21 |
| Elevated AST levels leading to dose reductions/interruptions | 2.8 % | · p.21 |
| 5-fold elevations above ULN for ALT | 4.8 % | · p.21 |
| Vomiting leading to dose reductions/interruptions | 2.8 % | · p.21 |
| Estimated patients diagnosed with ALK mutation-positive NSCLC | 9400 | · p.4 |
| Median survival for metastatic ALK mutation-positive NSCLC patients receiving crizotinib as first-line therapy | 20.8 months | · p.4 |
| Overall Response Rate (ORR) for alectinib in Study NP28761 | 44 % | Study NP28761 · p.4 |
| Hyperbilirubinemia leading to dose reductions/interruptions | 6 % | · p.21 |
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 →