Data updated: May 26, 2026
TAFINLAR (dabrafenib mesylate)
Genetically Validated
Trial Activity: Stable 36 active trials
Oncology
Approved 2013-05-29
Tafinlar is a targeted therapy used for patients with various cancers that harbor specific BRAF genetic mutations, such as the V600E or V600K variants. It helps patients with advanced melanoma, certain types of lung and thyroid cancers, and pediatric brain tumors. Doctors prescribe this medication either alone or alongside trametinib to manage tumors that are unresectable, have spread to other parts of the body, or require additional therapy after surgical removal.
Source: FDA Label • Novartis
How TAFINLAR Works
This drug works by inhibiting mutated BRAF kinases, which are proteins that can become permanently activated and drive uncontrolled tumor cell growth. By binding to these kinases, the medication blocks the signaling pathways that stimulate cancer progression. When used with trametinib, it targets two different points in the RAS/RAF/MEK/ERK pathway to more effectively inhibit tumor growth.
Development Insights
Novartis Pharmaceuticals conducting 21 trials (23%)
247 indications explored (Broad Platform)
→ melanoma (24 trials)
→ metastatic melanoma (11 trials)
→ cancer (8 trials)
13
Indications
--
Phase 3 Trials
7
Priority Reviews
12
Years on Market
Details
- Status
- Prescription
- First Approved
- 2013-05-29
- Patent Cliff
- 2038
- Routes
- ORAL, ORAL SUSPENSION
- Dosage Forms
- CAPSULE, TABLET, TABLET, FOR SUSPENSION
TAFINLAR Approval History
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
89 FDA actions from 2013 to 2026 · 11 indication expansions
Aug 2014 SUPPL
Mfg
What TAFINLAR Treats
4 indicationsTAFINLAR is approved for 4 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Melanoma
- Non-Small Cell Lung Cancer
- Anaplastic Thyroid Cancer
- Solid Tumors
Source: FDA Label
TAFINLAR Target & Pathway
ProTarget
A receptor that triggers cell growth, proliferation, and survival when activated. Mutations or overexpression of EGFR drive many cancers, particularly lung cancer. Blocking EGFR stops the growth signals that fuel tumor progression.
TAFINLAR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
3
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
3
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
Unlock 10 more competitors across all three rings.
Upgrade to Pro Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TAFINLAR's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TAFINLAR treats. First-in-class if their pivotal trials read out positive.
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials
Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Uliledlimab TJ004309
TJ Biopharma Co., Ltd. NT5E · monoclonal antibody (anti-CD73) · 1 Phase 3 trial
Drugs Similar to TAFINLAR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
AUGTYRO
REPOTRECTINIB
Bristol-Myers Squibb
Shared indications:
Non-Small Cell Lung CancerSolid Tumors
📋
Clinical Trial Registry
91 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01947023 | NCI-2013-01748 NCI-2013-01748, 13-061 | Ph 1 | active not recruiting | Dabrafenib and Lapatinib in Treating Patients With Refractory Thyroid Cancer That Cannot Be Removed by Surgery |
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT03919071 | NCI-2019-02289 NCI-2019-02289, ACNS1723 | Ph 2 | active not recruiting | Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma |
| NCT01989585 | NCI-2013-02103 NCI-2013-02103, 13-424 | Ph 1, Ph 2 | active not recruiting | Testing the Addition of Navitoclax to the Combination of Dabrafenib and Trametinib in People Who Have BRAF Mutant Melanoma |
| NCT02196181 | NCI-2014-01470 NCI-2014-01470, S1320 | Ph 2 | active not recruiting | Testing Two Different Treatment Schedules of Dabrafenib and Trametinib for Skin Cancer Which Has Spread |
| NCT04527549 results posted | EA6191 NCI-2020-04552, EA6191 | Ph 2 | terminated | Testing Dabrafenib and Trametinib With or Without Hydroxychloroquine in Stage IIIC or IV BRAF V600E/K Melanoma |
| NCT03975829 | CDRB436G2401 2023-509276-42-00 | Ph 4 | recruiting | Pediatric Long-Term Follow-up and Rollover Study |
| NCT06475989 | EA3231 NCI-2024-03023, EA3231 | Ph 3 | recruiting | Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer |
| NCT07110246 PNOC037 | 25081 NCI-2025-04985 | Ph 2 | recruiting | Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas |
| NCT04116541 MegaMOST | ET19-073 (MegaMOST) 2023-510567-35-00, 2019-001494-88 | Ph 2 | recruiting | A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors. |
| NCT03149029 results posted | 16-642 | Ph 2 | active not recruiting | Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma |
| NCT01682083 COMBI-AD results posted | 115532 2012-001266-15, CDRB436F2301 | Ph 3 | completed | Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). |
| NCT03340506 | CDRB436X2X02B 2023-509318-13-00 | Ph 4 | recruiting | Dabrafenib and/or Trametinib Rollover Study |
| NCT04439292 results posted | NCI-2020-03273 NCI-2020-03273, EAY131-H | Ph 2 | active not recruiting | Testing Trametinib and Dabrafenib as a Potential Targeted Treatment in Cancers With BRAF Genetic Changes (MATCH-Subprotocol H) |
| NCT03975231 | 21308 NCI-2019-02745, R01CA246553 | Ph 1 | recruiting | Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer |
| NCT07506109 | SICD-BRAF | Ph 2 | recruiting | A Phase II Study of Sintilimab Combined With Ipilimumab N01, Cetuximab and Dabrafenib in Patients With Microsatellite-Stable, BRAF V600E-Mutated Metastatic Colorectal Cancer |
| NCT04557956 | NCI-2020-07044 NCI-2020-07044, 202103077 | Ph 1, Ph 2 | active not recruiting | Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment |
| NCT03244956 MERAIODE | 2017-000742-21 2017/2527 | Ph 2 | completed | Efficacy of MEK (Trametinib) and BRAFV600E (Dabrafenib) Inhibitors With Radioactive Iodine (RAI) for the Treatment of Refractory Metastatic Differentiated Thyroid Cancer |
| NCT03091257 | 16-352 | Ph 1 | active not recruiting | A Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma |
| NCT07440290 DETERMINE | CRUKD/21/004 - Treatment Arm 7 | Ph 2, Ph 3 | not yet recruiting | DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers. |
| NCT04675710 | 2020-0641 NCI-2020-09803, 2020-0641 | Ph 2 | active not recruiting | Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer |
| NCT02224781 results posted | NCI-2014-01747 NCI-2014-01747, EA6134 | Ph 3 | active not recruiting | Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma |
| NCT04903119 | MCC-20-MEL-11-PMC 1R01CA258751-01A1 | Ph 1 | recruiting | Nilotinib Plus Dabrafenib/Trametinib or Encorafenib/Binimetinib in Metastatic Melanoma |
| NCT02231775 | 2014-0409 NCI-2014-01969, 2014-0409 | Ph 2 | active not recruiting | Dabrafenib and Trametinib Before and After Surgery in Treating Patients With Stage IIIB-C Melanoma With BRAF V600 Mutation |
| NCT04201457 | PBTC-055 UM1CA081457, NCI-2019-06216 | Ph 1, Ph 2 | active not recruiting | A Trial of Dabrafenib, Trametinib and Hydroxychloroquine for Patients With Recurrent LGG or HGG With a BRAF Aberration |
| NCT04452877 results posted | CDRB436ECN01 | Ph 2 | completed | A Study of Dabrafenib in Combination With Trametinib in Chinese Patients With BRAF V600E Mutant Metastatic NSCLC |
| NCT04294160 | CADPT01C12101 | Ph 1 | terminated | A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer |
| NCT02910700 | 2015-0605 NCI-2016-01940, 2015-0605 | Ph 2 | active not recruiting | Nivolumab With Trametinib and Dabrafenib, or Encorafenib and Binimetinib in Treating Patients With BRAF Mutated Metastatic or Unresectable Stage III-IV Melanoma |
| NCT01972347 Neo Combi | 200332 | Ph 2 | active not recruiting | Neoadjuvant Dabrafenib + Trametinib for AJCC Stage IIIB-C BRAF V600 Mutation Positive Melanoma |
| NCT04940052 | CDRB436J12301 | Ph 3 | active not recruiting | Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer |
| NCT04544111 | 20-258 | Ph 2 | active not recruiting | PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer |
| NCT02967692 COMBI-i results posted | CPDR001F2301 2016-002794-35 | Ph 3 | terminated | A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma |
| NCT04418167 | JSI-1187-01 | Ph 1 | suspended | JSI-1187-01 Monotherapy and in Combination With Dabrafenib for Advanced Solid Tumors With MAPK Pathway Mutations |
| NCT01723202 results posted | OSU-12064 NCI-2012-01700, NCCNGSK20008 | Ph 2 | completed | Dabrafenib With or Without Trametinib in Treating Patients With Advanced Differentiated Thyroid Cancer |
| NCT05388877 | MC210703 NCI-2022-04133, 22-000531 | Ph 1 | terminated | E6201 and Dabrafenib for the Treatment of Central Nervous System Metastases From BRAF V600 Mutated Metastatic Melanoma |
| NCT04238624 | 19-464 | Ph 2 | active not recruiting | Study of Cemiplimab Combined With Dabrafenib and Trametinib in People With Anaplastic Thyroid Cancer |
| NCT07010393 | Real-Neo | Ph 4 | not yet recruiting | Genotype-Driven Neoadjuvant Therapy for Locally Advanced Thyroid Cancer: A Real-World Cohort Study |
| NCT03551626 COMBI-APlus results posted | CDRB436F2410 2018-000168-27 | Ph 3 | completed | Study of Dabrafenib+Trametinib in the Adjuvant Treatment of Stage III BRAF V600+ Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes |
| NCT06119789 MATRIX-Rare | MATRIX-Rare | Ph 2 | recruiting | Precision Cancer Therapy in Rare Cancers |
| NCT03026517 | 15-318 | Ph 1 | completed | Clinical Trial of Phenformin in Combination With BRAF Inhibitor + MEK Inhibitor for Patients With BRAF-mutated Melanoma |
| NCT01902173 results posted | NCI-2013-01320 NCI-2013-01320, SWOG-S1221 | Ph 1, Ph 2 | completed | Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer |
| NCT06739395 | MyCustom-02 | Ph 2 | recruiting | Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion |
| NCT04310397 results posted | 2019-0906 NCI-2020-00941, 2019-0906 | Ph 2 | terminated | Dabrafenib, Trametinib, and Spartalizumab for the Treatment of BRAF V600E or V600K Mutation Positive Stage IIIB/C/D Melanoma |
| NCT06653517 NETCAM | NETCAM_2024CT | Ph 2 | recruiting | Clinical Study of Neoadjuvant Targeted Therapy for Ameloblastoma |
| NCT02097225 results posted | NCI-2014-00615 NCI-2014-00615, CTEP#9557 | Ph 1 | terminated | Onalespib, Dabrafenib, and Trametinib in Treating Patients With BRAF-Mutant Melanoma or Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery |
| NCT03455764 results posted | 17-656 | Ph 1, Ph 2 | completed | MCS110 With BRAF/MEK Inhibition in Patients With Melanoma |
| NCT05159245 FINPROVE | FINPROVE | Ph 2 | recruiting | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs |
| NCT04739566 ANAPLAST-NEO | 2 | Ph 2 | withdrawn | Dabrafenib and Trametinib Combination as a Neoadjuvant Strategy in BRAF-positive Anaplastic Thyroid Cancer |
| NCT03878524 | STUDY00015588 NCI-2020-02743, STUDY00015588 | Ph 1 | terminated | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial |
| NCT02367859 results posted | IRB-32275 NCI-2015-00169, ENT0043 | Ph 2 | completed | Dabrafenib and Trametinib in Treating Patients With BRAF Mutated Ameloblastoma |
Showing 50 of 91 trials
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Ongoing clinical trials by development phase
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Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TAFINLAR FDA Label Details
Indications & Usage
FDA Label (PDF)TAFINLAR is indicated for the treatment of Melanoma; Non-Small Cell Lung Cancer; Anaplastic Thyroid Cancer; Solid Tumors.
View full patent landscape →
14 OB patents · 4 families ·
201 international docs across 43 countries
TAFINLAR Patents & Exclusivity
Latest Patent: Dec 2038
Exclusivity: Sep 2030
Patents (14 active)
US11504333*PED
Expires Dec 29, 2038
US11504333
Expires Jun 29, 2038
US10869869*PED
Expires Feb 28, 2034
US10869869
Expires Aug 30, 2033
US8703781*PED
Expires Apr 15, 2031
US8952018*PED
Expires Apr 15, 2031
US8703781
Expires Oct 15, 2030
US8952018
Expires Oct 15, 2030
US8415345*PED
Expires Jul 20, 2030
US7994185*PED
Expires Jul 20, 2030
US8415345
Expires Jan 20, 2030
US7994185
Expires Jan 20, 2030
US9233956*PED
Expires Nov 4, 2029
US9233956
Expires May 4, 2029
Exclusivity
NP
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2030
PED
Until Sep 2026
NP
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2030
PED
Until Sep 2026
NP
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2030
PED
Until Sep 2026
I-908
Until Mar 2026
ODE-428
Until Mar 2030
I-908
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2030
PED
Until Sep 2030
PED
Until Sep 2026
PED
Until Sep 2026
I-908
Until Mar 2026
ODE-428
Until Mar 2030
I-908
Until Mar 2026
ODE-428
Until Mar 2030
PED
Until Sep 2030
PED
Until Sep 2030
PED
Until Sep 2026
PED
Until Sep 2026
Source: FDA Orange Book
Pro Intelligence Preview
Deep insights for TAFINLAR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 120 active patents
Trial Analysis
- • 93 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Unlock Full Intelligence
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment