NDAORALCAPSULEPriority Review
Approved
Dec 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
8/8 — 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 Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALECENSA (alectinib hydrochloride) is an oral ALK tyrosine kinase inhibitor approved by the FDA in December 2015 for the treatment of ALK-positive lung cancer and lymphoma. The drug works by inhibiting ALK phosphorylation and downstream signaling pathways (STAT3 and AKT) that drive tumor cell proliferation in ALK-fusion-positive cancers. Alectinib demonstrates activity against multiple ALK mutant forms, including those that confer resistance to first-generation ALK inhibitors like crizotinib, and has shown intracranial efficacy in preclinical models.
$0.2BPart D
9.0 years to LOEMechanism 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)
Worked on ALECENSA at Roche? Share your interview experience or compensation data (+7 days Pro)
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.