NDAORALTABLETPriority Review
Approved
Nov 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COTELLIC (cobimetinib) is an oral small-molecule MEK inhibitor approved in 2015 for treating BRAF-mutant melanoma, often used in combination with BRAF inhibitors. It works by blocking MEK signaling, a key pathway in melanoma cell proliferation. The drug is indicated for patients with unresectable or metastatic melanoma carrying BRAF V600E or V600K mutations.
$6.0MPart D
Peak10.5 years to LOEPeak-stage product with modest Part D utilization (1,110 claims in 2023) indicates a niche melanoma franchise requiring specialized oncology commercial expertise and targeted account management.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Belvarafenib in Combination With Cobimetinib in Patients With Locally Advanced or Metastatic NRAS-Mutant Melanoma
Started Feb 2026
45 enrolled
Advanced or Metastatic Melanoma
T3011 in Combination With Cobimetinib in Patients With Advanced Melanoma
Started Jun 2024
68 enrolled
MelanomaMalignant Melanoma
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
Calaspargase Pegol-Mnkl and Cobimetinib for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer
Started Aug 2022
15 enrolled
Locally Advanced Pancreatic AdenocarcinomaMetastatic Pancreatic AdenocarcinomaStage II Pancreatic Cancer AJCC v8+4 more
Cobimetinib In Extracranial Arteriovenous Malformations (COBI-AVM Study)
Started Jul 2022
3 enrolled
Arteriovenous Malformations (Extracranial)
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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.