dabrafenib
dabrafenib: developed by 1 company · 15 clinical trials tracked · 2 FDA decisions.
dabrafenib evidence translation
What we can confirm
2 FDA records · 15 tracked trials
What it means
What to watch
Prepared research question
How could dabrafenib → NVS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| Novartis AG (NVS) BRAF V600E Mutation-positive Unresectable Advanced or Recurr… | Approved |
Clinical Trials (15)showing 10 most recent
DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage/Young Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and TYA Patients With BRAF V600 Mutation-Positive Cancers.
Primary endpoint: Objective response (OR)
A Randomized Phase III Study of BRAF-Targeted Therapy vs Cabozantinib in RAI-Refractory Differentiated Thyroid Cancer With BRAF V600Em
Primary endpoint: Progression free survival (PFS)
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 Real-life Study to Evaluate the Use of Adjuvant Treatment With Dabrafenib and Trametinib in Routine Practice in Patients With Completely Resected High-risk Stage III Melanoma
Primary endpoint: Relapse-free survival (RFS) rate
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer (DTC)
Primary endpoint: Progression Free Survival (PFS)
The BAMM2 (BRAF, Autophagy, MEK Inhibition in Melanoma) Study: A Randomized Double Blind Phase II Study of Dabrafenib and Trametinib With or Without Hydroxychloroquine in Advanced BRAF V600E/K Melanoma With Elevated LDH
Primary endpoint: One-year Progression-free Survival Rate
Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection
Primary endpoint: Relapse-free survival (RFS)
An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)
Primary endpoint: Number of participants with Adverse Events and Serious Adverse Events (SAEs)
Phase I Study of INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.
Primary endpoint: Maximum Tolerated Dose
Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study
Primary endpoint: Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination
FDA Decisions2 records
Frequently asked questions
Who is developing dabrafenib?
dabrafenib is being developed by Novartis AG.
How many clinical trials involve dabrafenib?
BioSniper tracks 15 clinical trials involving dabrafenib.
What is dabrafenib's latest FDA decision?
The most recent tracked FDA decision for dabrafenib is Approval, dated March 16, 2023.