NDAORALCAPSULEPriority Review
Approved
Dec 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
7/8 — Comprehensive
Priority Review
ALECENSA (alectinib hydrochloride) by Roche is ret. Approved for lung cancer, lung cancer, lymphoma. First approved in 2015.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALECENSA (alectinib hydrochloride) is an oral, small-molecule ALK inhibitor approved for ALK-positive non-small cell lung cancer and lymphoma. It works by inhibiting ALK phosphorylation and downstream signaling proteins (STAT3, AKT), demonstrating activity against crizotinib-resistant ALK mutations. The drug and its active metabolite M4 show robust preclinical and clinical efficacy in both systemic and intracranial ALK-driven tumors.
$0.186BPart D
Peak8.7 years to LOEALECENSA is in peak commercial phase with established market presence; brand teams should expect stable resource allocation with focus on market maintenance and patient access programs.
Mechanism of Action
RET. In nonclinical studies, alectinib inhibited ALK phosphorylation and ALK-mediated activation of the downstream signaling proteins STAT3 and AKT, and decreased tumor cell viability in multiple cell lines harboring ALK fusions, amplifications, or activating mutations. The major active metabolite…
Indications (2)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.