binimetinib
binimetinib: developed by 1 company · 16 clinical trials tracked · 1 FDA decision.
binimetinib evidence translation
What we can confirm
1 FDA record · 16 tracked trials
What it means
What to watch
Prepared research question
How could binimetinib → ARRY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 7 study sponsors
Related indications
Development Pipeline (1)
| Company | Phase |
|---|---|
| ARRAY BIOPHARMA INC (ARRY) unresectable or metastatic melanoma with a BRAF V600E or BRA… | Approved |
Clinical Trials (16)showing 10 most recent
Molecular Targeted Maintenance Therapy Versus Standard of Care in Advanced Biliary Cancer: an International, Randomised, Controlled, Open-label, Platform Phase 3 Trial
Primary endpoint: Progression-free survival (PFS)
FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations: A ComboMATCH Treatment Trial
Primary endpoint: Overall survival (OS)
Molecular Analysis for Combination Therapy Choice (ComboMATCH)
Primary endpoint: Accrual of patients to ComboMATCH treatment trials
A Phase 1 Study of ZEN003694 in Combination With Binimetinib in Solid Tumors With RAS Pathway Alterations and Triple Negative Breast Cancer
Primary endpoint: Incidence of dose limiting toxicities (Part 1 [Dose Escalation])
A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTI TUMOR ACTIVITY OF PF-07799933 (ARRY-440) AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 16 YEARS AND OLDER WITH ADVANCED SOLID TUMORS WITH BRAF ALTERATIONS
Primary endpoint: Number of participants with dose limiting toxicities (DLTs) (Part 1 and Part 2)
A Phase 1 Study of Nilotinib in Combination With Dabrafenib and Trametinib or Encorafenib/Binimetinib in BRAF V600 Mutant Metastatic Melanoma After Progression on BRAF/MEK Inhibition
Primary endpoint: Percentage of Patients Experiencing Dose Limiting Toxicities
A Phase II Study of Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma
Primary endpoint: Overall Response Rate
A Phase II Neoadjuvant Study of Encorafenib With Binimetinib in Patients With Resectable Locoregional Metastases From Cutaneous or Unknown Primary Melanoma (Stages III N1B/C/D)
Primary endpoint: Pathologic Complete Response
A Phase 1/2, First-in-Human Study of DCC-3116 as Monotherapy and in Combination With RAS/MAPK Pathway Inhibitors in Patients With Advanced or Metastatic Solid Tumors With RAS/MAPK Pathway Mutations
Primary endpoint: Incidence of Adverse Events
A Phase II Study of Binimetinib in Combination With Imatinib in Patients With Advanced KIT-Mutant Melanoma
Primary endpoint: Objective response rate (ORR)
FDA Decisions1 records
Frequently asked questions
Who is developing binimetinib?
binimetinib is being developed by ARRAY BIOPHARMA INC.
How many clinical trials involve binimetinib?
BioSniper tracks 16 clinical trials involving binimetinib.
What is binimetinib's latest FDA decision?
The most recent tracked FDA decision for binimetinib is Approval for 1 INDICATIONS AND USAGE MEKTOVI is a kinase inhibitor indicated: • in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. ( 1.1 , 2.1 ) • in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test. ( 1.2 , 2.1 ) 1.1 BRAF V600E or V600K Mutation-Positiv, dated June 27, 2018.