NDAORALTABLETPriority Review
Approved
Aug 2011
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
ZELBORAF (vemurafenib) by Roche is protein kinase inhibitors [moa]. First approved in 2011.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZELBORAF (vemurafenib) is an oral small-molecule protein kinase inhibitor approved in 2011 for the treatment of melanoma and other BRAF V600E-mutant malignancies. It works by selectively inhibiting BRAF kinase, a driver mutation in approximately 50% of melanomas, blocking tumor cell proliferation. The drug represents a paradigm shift in precision oncology, targeting patients with specific genetic mutations rather than histology alone.
$13MPart D
Peak5.6 years to LOEProduct is in peak lifecycle stage with established market presence and stable commercial infrastructure, though team size may reflect maturity rather than expansion.
Mechanism of Action
Protein Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL)
Started Sep 2024
86 enrolled
Hairy Cell Leukemia
Efficacy and Safety of Tunlametinib Plus Vemurafenib in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Started Oct 2023
165 enrolled
Colorectal Cancer Metastatic
Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase II Clinical Study
Started Sep 2023
75 enrolled
Non-small-cell Lung Cancer
DETERMINE Trial Treatment Arm 05: Vemurafenib in Combination With Cobimetinib in Adult Patients With BRAF Positive Cancers.
Started Mar 2023
30 enrolled
Haematological MalignancyMelanomaThyroid Cancer, Papillary+9 more
Phase II Trial of Vemurafenib and Sorafenib in Pancreatic Cancer
Started Oct 2021
10 enrolled
Pancreas Cancer
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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.